MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-26 for BALLOON CATHETER 93508C23 manufactured by Edwards Lifesciences Llc.
[103604353]
During transcatheter pulmonary valve replacement, balloon used for dilation ruptured during inflation. Balloon pieces were retrieved without difficulty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076117 |
| MDR Report Key | 7372973 |
| Date Received | 2018-03-26 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-03-07 |
| Date Added to Maude | 2018-03-27 |
| 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 |
| 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 | 3 |
| Brand Name | BALLOON CATHETER |
| Generic Name | CATHETER/PERCUTANEOUS VALVULOPLASTY. |
| Product Code | MAD |
| Date Received | 2018-03-26 |
| Catalog Number | 93508C23 |
| Lot Number | 60460916 |
| Device Expiration Date | 2018-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES LLC |
| Manufacturer Address | IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-26 |