MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-06 for Z MED II BALLOON 618733 manufactured by B Braun Medical.
[91219477]
During balloon aortic valvuloplasty, the balloon initially inflated but ruptured. As a result, this balloon was removed and another balloon was inflated successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073137 |
| MDR Report Key | 7002805 |
| Date Received | 2017-11-06 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-20 |
| Date Added to Maude | 2017-11-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | Z MED II BALLOON |
| Generic Name | 18 MM BALLOON AORTIC VALVULOPLASTY |
| Product Code | OZT |
| Date Received | 2017-11-06 |
| Model Number | 618733 |
| Lot Number | ZZX1936 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-06 |