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 2020-03-31 for WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3852 manufactured by Boston Scientific Corporation.
[185945092]
Patient identifier: (b)(6). Age at time of event: 18 years or older.
Patient Sequence No: 1, Text Type: N, H10
[185945093]
It was reported that balloon rupture occurred. The patient presented with chest pain. Vascular access was obtained via the right radial artery. The 70% stenosed, 3. 0mmx15mm, concentric, de novo, was in a moderately tortuous and moderately calcified ostial left anterior descending artery with a significant bend less than or equal to 45 degrees. A 3. 00x15mm wolverine coronary cutting balloon was advanced for treatment. During the procedure, it was noted that the balloon ruptured upon the first inflation at 4-6atm. The device was removed as a whole system from the sheath. The procedure was completed with a 3. 00x10mm wolverine balloon inflated to 12 atm with no issues. No complications were reported and the patient was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-04042 |
| MDR Report Key | 9904485 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-12-11 |
| Date Added to Maude | 2020-03-31 |
| 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 | 2020-03-31 |
| Model Number | 3852 |
| Catalog Number | 3852 |
| Lot Number | 0024915394 |
| 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 | 2020-03-31 |