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 1998-04-24 for INOUE-BALLOON PTMC-26 manufactured by Toray Industries, Inc..
[7768373]
The guidewire of which the distal end had been broken and left in the left atrium of the pt in china was returned to co for evaluation. Visual inspection and physical testing were performed in co's laboratory and it was confirmed that the product had been made by co. No defects of the fabrication or material of the guidewire were identified. On the other hand, rust was noted on the proximal end of the coil, which was on the verge of being broken. This suggests the guidewire had been reused many times. Unfortunately, the lot number of the guidewire has not been identified. It is also unclear how many times the device had been reused.
Patient Sequence No: 1, Text Type: N, H10
[14871087]
It was reported that an accident happened in a pt undergoing ptmc operation using a reused inoue-balloon catheter and a reused guidewire in china. The distal portion of the guidewire was broken and left behind inside the right atrium. A small part of its tip trapping across the puncture hole of the atrium septum and its lower part extending down to the opening of the inferior vena cava. X-ray screening for the pt on march 30, 1998 showed that the broken part of the right branch of the pulmonary artery. Aspirin tablet was administered to the pt to prevent blood clotting. The dosage given was 70mg per day. The status of the pt is still stable for the time being. The doctor who performed the ptmc procedure decided to leave the broken part of the guidewire as it was because he judged it would not cause any further problem for the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649869-1998-00003 |
| MDR Report Key | 164254 |
| Report Source | 01,07,08 |
| Date Received | 1998-04-24 |
| Date of Report | 1998-04-24 |
| Date of Event | 1998-02-01 |
| Date Mfgr Received | 1998-03-27 |
| Date Added to Maude | 1998-04-28 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INOUE-BALLOON |
| Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Product Code | MAD |
| Date Received | 1998-04-24 |
| Returned To Mfg | 1998-04-23 |
| Model Number | PTMC-26 |
| Catalog Number | PTMC-26 |
| Lot Number | UNK |
| ID Number | * |
| 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 | 159880 |
| Manufacturer | TORAY INDUSTRIES, INC. |
| 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-26 |
| Baseline Catalog No | PTMC-26 |
| 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 | 1998-04-24 |