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 2020-03-11 for WOLVERINE CORONARY CUTTING BALLOON MONORAIL 3852 manufactured by Boston Scientific Corporation.
[183116191]
Date of event: the date of the event is unknown. Bsc became aware of the event on (b)(6)2019. Therefore, a date of (b)(6) 2019 has been entered to indicate that the event occurred on an unknown day in (b)(6) 2019. (b)(6). Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. Blood was identified within the balloon and lumen which is evidence of a device leak. The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon. The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen. The device was soaked in a water bath to help soften the media before further inflation attempts were made. The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located approximately 3mm distal to the distal end of the proximal markerband. An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint. A visual and tactile examination identified no kinks or damage to the shaft or hypotube of the returned device. The markerbands, tip and blades of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident. All blades were present and fully bonded to the balloon material. No issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[183116192]
Reportable based on analysis completed on 19feb2020. It was reported that failure to inflate and damage to a balloon occurred. A 15mm x 2. 50mm wolverine coronary cutting balloon was advanced to the target lesion, but the balloon was unable to inflate. It was noted that the device was damaged but without any cause or visibly damage from the physician. The procedure was completed with another of the same device. No patient complications were reported in relation to this event and the patient was reported to be stable following the procedure. However, device analysis revealed a pinhole in the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02650 |
| MDR Report Key | 9819680 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-09-17 |
| Date Added to Maude | 2020-03-11 |
| 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 CORPORATION |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-01-07 |
| Model Number | 3852 |
| Catalog Number | 3852 |
| Lot Number | 0024441117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-11 |