MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-16 for WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3851 manufactured by Boston Scientific Corporation.
[183568665]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[183568666]
It was reported that a balloon rupture occurred. The 75% stenosed target lesion was located in a moderately tortuous and severely calcified mid left anterior descending artery. A 10mmx2. 75mm wolverine coronary cutting balloon was selected for use. During the procedure, the wolverine was inserted, but it was unable to cross due to severe calcification. Consequently, dilation was performed, however at the fourth dilation, it was noticed that the balloon ruptured at 12atm before the lesion. The device was removed without any problems. The procedure was completed with a different device. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02734 |
| MDR Report Key | 9836113 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-09-04 |
| Date Added to Maude | 2020-03-16 |
| 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 MONORAIL |
| Generic Name | CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING |
| Product Code | NWX |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 3851 |
| Catalog Number | 3851 |
| Lot Number | 0024373426 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 6 | 2020-03-16 |