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 2020-03-17 for ROTAPRO 3243 manufactured by Boston Scientific Corporation.
[183879283]
It was reported that catheter entrapment on the guidewire occurred. A 1. 25mm rotapro and a rotawire were selected for an atherectomy procedure in the left anterior descending artery (lad). During the procedure, difficulty occurred introducing the guidewire into the burr. Upon removal, the burr catheter became stuck on the guidewire. The catheter and the guidewire were removed together as one system from the patient. The burr was disconnected from the advancer and it was noted that the shaft of the rotapro was twisted. The procedure was completed with another burr and guidewire. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03363 |
| MDR Report Key | 9841454 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-10-15 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 CORPORATION |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK IRELAND |
| Manufacturer Country | EI |
| Manufacturer Postal Code | IRELAND |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTAPRO |
| Generic Name | CATHETER, CORONARY, ATHERECTOMY |
| Product Code | MCX |
| Date Received | 2020-03-17 |
| Model Number | 3243 |
| Catalog Number | 3243 |
| Lot Number | 0024597713 |
| 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 | 2020-03-17 |