MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 1999-08-05 for INOUE BALLOON CATHETER PTMC-22 manufactured by Toray Industries, Inc..
[158324]
At the time of inflation of inoue-balloon catheter, the doctor found acute mitral regurgitation, and the patient had to undergo mitral valve replacement as an emergency procedure. The patient survived after surgery and is doing well on follow-up. The outer latex of the balloon ruptured and the cord of mitral valve ruptured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649869-1999-00002 |
| MDR Report Key | 234801 |
| Report Source | 01,07,08 |
| Date Received | 1999-08-05 |
| Date of Report | 1999-07-08 |
| Date of Event | 1999-04-06 |
| Date Mfgr Received | 1999-07-08 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 1999-08-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOUE BALLOON CATHETER |
| Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Product Code | MAD |
| Date Received | 1999-08-05 |
| Model Number | PTMC-22 |
| Catalog Number | PTMC-22 |
| Lot Number | SEP-21-1998 |
| ID Number | * |
| Device Expiration Date | 2000-09-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 227547 |
| Manufacturer | TORAY INDUSTRIES, INC. |
| Manufacturer Address | SETA PLANT 1-1, OE 1-CHOME OTSU-SHI, SHIGA JA 520-2141 |
| Baseline Brand Name | INOUE BALLOON CATHETER |
| Baseline Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Baseline Model No | PTMC-22 |
| Baseline Catalog No | PTMC-22 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-08-05 |