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 2020-03-25 for WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3851 manufactured by Boston Scientific Corporation.
[187084892]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[187084893]
It was reported that the catheter shaft broke. The target lesion was located in the severely calcified circumflex artery. A 10mmx3. 00mm wolverine coronary cutting balloon was selected for use. During the procedure, after dilatation was performed with a bsc imaging catheter, it was noted that device was able to cross up to the midway of the lesion. A non-bsc guide extension catheter was used in combination. Furthermore, when the device was removed after deflation, resistance was met, so it was tried to expand again and removed, but it failed. After it was tried to remove again forcibly, it was noted that around 10cm of the shaft got separated from the tip of the device. Then, the section from the separated part to the tip was pulled out from the patient's body using a guiding catheter and guide extension in combination. The device was completely removed from the patient's body and the procedure was completed with the original device. No further complications were reported and the patient was good post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03670 |
| MDR Report Key | 9880239 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-12-05 |
| Date Added to Maude | 2020-03-25 |
| 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 | 2020-03-25 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 3851 |
| Catalog Number | 3851 |
| Lot Number | 0024879720 |
| 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 | 1. Required No Informationntervention | 2020-03-25 |