Table 1.
Reports of the Turnpike catheters failure in MAUDE registry.
| Total number of events | 194 |
|---|---|
| Year of event | |
| 2015, n(%) | 14 (7.2%) |
| 2016, n(%) | 39 (20.0%) |
| 2017, n(%) | 38 (19.5%) |
| 2018, n(%) | 35 (17.9%) |
| 2019, n(%) | 23 (11.8%) |
| 2020, n(%) | 27 (13.8%) |
| 2021, n(%) | 15 (7.7%) |
| Unidentified, n(%) | 2 (1%) |
| Turnpike VCD type | |
| Turnpike Spiral, n(%) | 76 (39.4%) |
| Turnpike Smooth, n(%) | 18 (9.3%) |
| Turnpike LP, n(%) | 62 (31.1%) |
| Turnpike Gold, n(%) | 2 (1.0%) |
| Unidentified, n(%) | 36 (18.1%) |
| Target vessel | |
| RCA, n(%) | 31 (16.1%) |
| LAD, n(%) | 27 (14.0%) |
| LCX, n(%) | 10 (5.2%) |
| LMCA, n(%) | 2 (1.0%) |
| Other, n(%) | 16 (8.3%) |
| Insufficient information, n(%) | 107 (55.4%) |
| Severely calcified vessel, n(%) | 69 (35.8%) |
| Over-torquing, n(%) | 64 (33.2%) |
| Failure method | |
| Detachment, or break, n(%) | 164 (85%) |
| Entrapment, n(%) | 7 (3.5%) |
| Failed engagement, n(%) | 9 (4.7%) |
| Insufficient information, n(%) | 1 (0.5%) |
| None, n(%) | 12 (6.2%) |
| Clinical consequence | |
| Major bleeding (Hypotension), n(%) | 0 (0%) |
| Vessel occlusion, n(%) | 7 (3.6%) |
| Vessel injury, n(%) | 15 (7.8%) |
| Hematoma, n(%) | 1 (0.5%) |
| Retroperitoneal hematoma, n(%) | 0 (0%) |
| Catheter Entrapment, n(%) | 65 (33.2%) |
| Insufficient information, n(%) | 30 (15.5%) |
| None | 76 (39.4%) |
| Patient outcome | |
| Death, n(%) | 4 (2.0%) |
| No consequences, n(%) | 93 (47.0%) |
| Recovered, n(%) | 22 (11.1%) |
| Insufficient information, n(%) | 75 (37.9%) |
MAUDE: Manufacturer and User Facility Device Experience, RCA: Right coronary artery, LAD: Left anterior descending artery, LCX: Left circumflex artery, LMCA: Left main coronary artery.