MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1997-02-14 for INOUE BALLOON CATHETER PTMC-26 manufactured by Toray Industries, Inc..
[45107]
During valvuloplasty procedure using balloon catheter, left atrial wall was perforated. Hypotension and pericardial tamponade were noted while operator was manipulating catheter across interatrial septum. Surgical repair was required. Pt has recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433215-1997-00001 |
| MDR Report Key | 70006 |
| Report Source | 05,07 |
| Date Received | 1997-02-14 |
| Date of Report | 1997-02-14 |
| Date of Event | 1996-12-02 |
| Date Mfgr Received | 1997-01-16 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 1997-02-21 |
| 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 | 3 |
| 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 | 1997-02-14 |
| Model Number | PTMC-26 |
| Catalog Number | PTMC-26 |
| Lot Number | 12-19-1995 |
| ID Number | * |
| Device Expiration Date | 1997-12-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 69934 |
| Manufacturer | TORAY INDUSTRIES, INC. |
| Manufacturer Address | 1-1 OE 1-CHOME SETA PLANT OTSU-SHI SHIGA JA 250-21 |
| 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. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 1997-02-14 |