MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for WOLVERINE CORONARY CUTTING BALLOON 3855 manufactured by Boston Scientific Corporation.
[185667449]
It was reported that the catheter shaft broke. The target lesion was located in the mild to moderately calcified left anterior descending artery. A 15mmx3. 50mm wolverine coronary cutting balloon was selected for use. During the procedure, when the device was introduced, it was noted that it would not pass the curve of the guide catheter. The device, while inside the guide catheter, was simply removed from the patient's body. Then, as the device inside the guide catheter was manipulated on the back table, it was noted that the shaft was broken in two pieces. Furthermore, it was also noted that the device became kinked while inside the guide catheter. The device was removed from the guide catheter after manipulating on the back table and the procedure was completed with a different device. No complications were reported and the patient was fine post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03974 |
| MDR Report Key | 9898071 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2020-01-21 |
| Date Added to Maude | 2020-03-30 |
| 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 IRELAND LIMITED |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WOLVERINE CORONARY CUTTING BALLOON |
| Generic Name | CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING |
| Product Code | NWX |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-30 |
| Model Number | 3855 |
| Catalog Number | 3855 |
| Lot Number | 0025074241 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-30 |