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 2020-03-13 for WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3851 manufactured by Boston Scientific Corporation.
[183327636]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183327637]
It was reported that a balloon rupture occurred. The 75% superficially stenosed target lesion area was located in a mildly tortuous and mildly calcified mid to the distal right coronary artery. A 10mmx3. 50mm wolverine cutting balloon was selected for use. During the procedure, it was noted that the balloon device was able to cross the lesion, but the balloon ruptured when a pressure of 4atm was applied. The procedure was completed with a different device. No patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02384 |
| MDR Report Key | 9828613 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-11-24 |
| Date Added to Maude | 2020-03-13 |
| 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 | 2020-03-13 |
| Model Number | 3851 |
| Catalog Number | 3851 |
| Lot Number | 0024822784 |
| 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 | 2020-03-13 |