MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2000-10-25 for INOUE BALLOON CATHETER PTMC-28 manufactured by Toray Industries, Inc./seta Plant.
[16620441]
During a mitral valvuloplasty procedure with the inoue balloon catheter, the distal tip of the guidewire has separated inside the pt. The distal tip of the guidewire is stuck and remained at the pt's tricuspid. The distal tip of the guidewire will be left in the pt for two weeks, and at that time it will be determined if add'l treatment is necessary. The pt is completely stable.
Patient Sequence No: 1, Text Type: D, B5
[19954905]
The pt was admitted on 09/22/00 for percutaneous transvenous mitral commissurotomy. This was performed without difficulty. Upon removal of the inoue balloon, the coiled distal tip of wire frayed and separated from the catheter system and hung on the tricuspid apparatus. The system was removed and the frayed wire remained. An attempt to retrieve the wire tip with 25mm snare was unsuccessful as the wire fractured just proximal to the distal tip. A spiral ct revealed the presence of the small wire tip within the right arterial tricuspid apparatus. No interventions were felt to be necessary as the wire appeared to be immobile on both echocardiographic and ct testing. Fluoroscopic eval also demonstrated no free movement. The pt was placed on lovenox an coumadin therapy, and was discharged on 09/25/00. The pt had a follow up echocardiogram. Two months later, pt had a mitral valve replacement. The wire tip was removed during the procedure without any complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614758-2000-00004 |
| MDR Report Key | 302063 |
| Report Source | 00,05,06,07 |
| Date Received | 2000-10-25 |
| Date of Report | 2000-09-26 |
| Date of Event | 2000-09-22 |
| Date Mfgr Received | 2000-09-26 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2000-10-31 |
| 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 |
| Manufacturer Contact | HIDEHIKO OKUBO, DIRECTOR |
| Manufacturer Street | 600 THIRD AVE |
| Manufacturer City | NEW YORK NY 10016 |
| Manufacturer Country | US |
| Manufacturer Postal | 10016 |
| Manufacturer Phone | 2126978150 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2000-10-25 |
| Returned To Mfg | 2000-10-06 |
| Model Number | PTMC-28 |
| Catalog Number | PTMC-28 |
| Lot Number | JAN.20.2000 |
| ID Number | * |
| Device Expiration Date | 2002-01-20 |
| 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 | 292359 |
| Manufacturer | TORAY INDUSTRIES, INC./SETA PLANT |
| Manufacturer Address | 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-28 |
| Baseline Catalog No | PTMC-28 |
| Baseline ID | NONE |
| Baseline Device Family | INOUE BALLOON CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9100 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-10-25 |