MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2009-08-27 for INOUE BALLOON CATHETER PTMC-30 manufactured by Toray Industries Inc..
[1230285]
A woman underwent percutaneous transvenous mitral commissurotomy (ptmc) with ptmc-30 inoue balloon catheter in 2009. The physician who performed the procedure, reported that the abnormal inflation of the balloon occurred during the procedure. The pt's mitral valve was torn after the balloon inflation, and the mitral valve regurgitation occurred. The surgical treatment was required, and mitral valve replacement was conducted. The condition of the pt is good and the pt was released from the hospital at an approximately one month later. The detailed investigation is being executed to the medical institution now.
Patient Sequence No: 1, Text Type: D, B5
[8281946]
The balloon catheter used in the ptmc procedure has not been returned to the manufacturer, so eval test for the concerned device has not been performed yet. In addition, we are investigating the add'l info about the event to the medical institution. After confirming the add'l info about the device and the event, follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612812-2009-00001 |
| MDR Report Key | 1457715 |
| Report Source | 01,05,08 |
| Date Received | 2009-08-27 |
| Date of Report | 2009-07-31 |
| Date of Event | 2009-07-05 |
| Date Mfgr Received | 2009-07-31 |
| Date Added to Maude | 2009-09-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | HIROSHI OHNO, PH.D, DIR |
| Manufacturer Street | 461 FIFTH AVENUE, 9TH FLOOR |
| Manufacturer City | NEW YORK NY 10017 |
| Manufacturer Country | US |
| Manufacturer Postal | 10017 |
| Manufacturer Phone | 2126978150 |
| Manufacturer G1 | TORAY INDUSTRIES, INC. SETA PLANT |
| Manufacturer Street | 1-1 OE, 1-CHOME |
| Manufacturer City | OTSU-SHI, SHIGA 520-2141 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 520-2141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOUE BALLOON CATHETER |
| Product Code | MAD |
| Date Received | 2009-08-27 |
| Catalog Number | PTMC-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORAY INDUSTRIES INC. |
| Manufacturer Address | CHUO-KU, TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2009-08-27 |