MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for ROTALINK PLUS 3241 manufactured by Boston Scientific Corporation.
[183256911]
It was reported that the device fractured and fluid leaked. The significantly stenosed target lesion was located in a heavily calcified coronary artery. A 1. 50mm rotalink plus was selected for use. At the course of the procedure, the first three runs were smooth with little to no fluctuations in the rpm. However, during the fourth run, the speed varied from 132-152rpm and ablation was aborted. Consequently, the system was manually pulled out over the rotawire. The device was then pulled out while in dynaglide mode and the machine stalled. Then, the device was back into the guide catheter and it was noted that the top section of the outside of the burr catheter snapped and the rotamix was dripping from the snapped point approximately half way along the system. The defect was contained within the guide catheter and the system was manually pulled out over the rotawire and safely removed from the patient. The physician's opinion was that the fault occurred midway along the rota sheath/shaft. The sheath had an imperfection that created a hole in the tubing during rotablation and resulted to the rota-flush fluid to exit this hole under pressure. As such no fluid was flushing out of the distal end of the rota sheath, resulting in friction between the rota shaft and sheath and deceleration of revolutions and eventually a stall. No patient complications were reported and patient was stable post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03121 |
| MDR Report Key | 9825143 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-06-24 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTALINK PLUS |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-12 |
| Model Number | 3241 |
| Catalog Number | 3241 |
| Lot Number | 0023999162 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |