MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 1998-10-13 for VALVULOPLASTY CATHETER OWENS STIFF EXTRUS 20-3/9 H74920060 manufactured by Scimed Life Systems, Inc. A Subsidiary Of Boston Scientific Corporation.
[119427]
It was reported that during a pericardiotomy procedure, the valvuloplasty balloon ruptured and the balloon became separated from the shaft. All pieces were successfully retrieved. The patient status is listed as "okay".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000060-1998-00073 |
| MDR Report Key | 192047 |
| Report Source | 06,07 |
| Date Received | 1998-10-13 |
| Date of Report | 1998-09-18 |
| Date of Event | 1998-09-14 |
| Date Facility Aware | 1998-09-14 |
| Report Date | 1998-09-18 |
| Date Mfgr Received | 1998-09-18 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 1998-10-20 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALVULOPLASTY CATHETER |
| Generic Name | VALVULOPLASTY CATHETER |
| Product Code | MAD |
| Date Received | 1998-10-13 |
| Returned To Mfg | 1998-10-05 |
| Model Number | OWENS STIFF EXTRUS 20-3/9 |
| Catalog Number | H74920060 |
| Lot Number | 1359894 |
| ID Number | NA |
| Device Expiration Date | 2000-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 186616 |
| Manufacturer | SCIMED LIFE SYSTEMS, INC. A SUBSIDIARY OF BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 6655 WEDGWOOD ROAD MAPLE GROVE MN 55311 US |
| Baseline Brand Name | VALVULOPLASTY CATHETER |
| Baseline Generic Name | VALVULOPLASTY CATHETER |
| Baseline Model No | OWENS STIFF EXT |
| Baseline Catalog No | H74920060 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-10-13 |