MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for PTA BALLOON DILITATION CATHETER CHARGER 12MM X 60MM 75CM SHAFT H74939206120670 manufactured by Boston Scientific Corporation.
[183638853]
Vascular pta balloon rupture. Max inflation pressure not reached. Provider wasn't able to suck the balloon down due to rupture. Upon removal the tip of the balloon broke off, f/u ct scan showed the fragment in the femoral mein. Balloon burst even though rated burst pressure hadn't been achieved. Upon withdrawal of the balloon through the sheath in the femoral vein, the distal part of the balloon separated and lodged in the vein. We believe this happened because the unwrapped balloon material caught on the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093705 |
| MDR Report Key | 9824485 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-19 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PTA BALLOON DILITATION CATHETER CHARGER 12MM X 60MM 75CM SHAFT |
| Generic Name | CATHETER, ANGIOPLASTY, PERIPHERAL TRANSLUMINAL |
| Product Code | NVM |
| Date Received | 2020-03-11 |
| Model Number | H74939206120670 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Brand Name | CHARGER 12MM X 60MM 75 SHAFT |
| Product Code | --- |
| Date Received | 2020-03-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |