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 2004-08-31 for INOUE BALLOON CATHETER IMS-26 manufactured by Toray Industries, Inc..
[329569]
A pt with an echocardiograph score of 6 underwent percutaneous transvenous mitral commissurotomy (ptca) with ims-26 inoue balloon catheter in 2004. The physician who performed the procedure reported that the balloon "ruptured" during the procedure, and the balloon catheter was withdrawn from the left atrium in accordnace with the "instructions for use. " before assessing the pt's hemodynamic function, the physician completed the procedure using a new ims-26 balloon catheter. Following the second procedure, the pt was found to have mitral regurgitation grade 3. The pt was given ace inhibitor and nitroglyerine. An echocardigraph performed three days after the procedure showed mitral regurgitation grade 2. Surgical treatment was not required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614758-2004-00001 |
| MDR Report Key | 542066 |
| Report Source | 01,07,08 |
| Date Received | 2004-08-31 |
| Date of Report | 2004-06-22 |
| Date of Event | 2004-06-16 |
| Date Mfgr Received | 2004-06-22 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2004-09-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KOJI HAGIMOTO, DIRECTOR |
| Manufacturer Street | 461 FIFTH AVE, 9TH FL |
| 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, 0E 1-CHOME OTSU-SHI |
| Manufacturer City | SHIGA, 520-2141 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 520-2141 |
| 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 | 2004-08-31 |
| Returned To Mfg | 2004-07-08 |
| Model Number | NA |
| Catalog Number | IMS-26 |
| Lot Number | 021227 |
| ID Number | NA |
| Device Expiration Date | 2004-12-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 531414 |
| Manufacturer | TORAY INDUSTRIES, INC. |
| Manufacturer Address | * OTSU-SHI, SHIGA JA |
| Baseline Brand Name | INOUE BALLOON CATHETER |
| Baseline Generic Name | BALLOON VAVULOPLASTY CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | IMS-26 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2004-08-31 |