MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 1999-07-15 for INOUE BALLOON CATHETER GMS-1 manufactured by Toray Industries, Inc. Seta Plant.
[16278106]
During a "ptmc" procedure, when the inoue-balloon catheter was inserted to the left atrium the spring coil at the tip of the guidewire was broken and floated in the patient. The doctor fished out the broken portion by using another catheter. After the doctor fished out the broken portion, the condition of the patient was alright. The guidewire appeared to have been reused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649869-1999-00001 |
| MDR Report Key | 232069 |
| Report Source | 01,05,07,08 |
| Date Received | 1999-07-15 |
| Date of Report | 1999-07-15 |
| Date of Event | 1999-06-16 |
| Date Mfgr Received | 1999-06-16 |
| Device Manufacturer Date | 1997-12-01 |
| Date Added to Maude | 1999-07-20 |
| 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 | 1999-07-15 |
| Returned To Mfg | 1999-06-22 |
| Model Number | GMS-1 |
| Catalog Number | GMS-1 |
| Lot Number | DEC-19-1997 |
| ID Number | * |
| Device Expiration Date | 1999-12-19 |
| 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 | 224961 |
| Manufacturer | TORAY INDUSTRIES, INC. SETA PLANT |
| Manufacturer Address | 1-1 OE 1-CHOME OTSU-SHI, SHIGA JA 520-2141 |
| Baseline Brand Name | INOUE BALLOOON CATHETER |
| Baseline Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Baseline Model No | GMS-1 |
| Baseline Catalog No | GMS-1 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-15 |