MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for INOUE BALLOON CATHETER PTMC-28 manufactured by Toray.
[29938574]
Pt. For mitral valvuloplasty utilizing inoue-balloon system. Balloon rupture during inflation in patient's mitral valve area possibly due to mitral valve physiology.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057497 |
| MDR Report Key | 5187426 |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-09-29 |
| Date Added to Maude | 2015-10-29 |
| 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 | 0 |
| Brand Name | INOUE BALLOON CATHETER |
| Generic Name | INOUE BALLOON CATHETER |
| Product Code | MAD |
| Date Received | 2015-10-26 |
| Model Number | PTMC-28 |
| Lot Number | 16300BZZ01718000 |
| Device Expiration Date | 2016-11-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAY |
| Manufacturer Address | CHOU-KU TOKYO 103-0023 JA 103-0023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-26 |