MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1997-10-03 for VALVULOPLASTY CATHETER OWENS LO-PROFILE 2617 manufactured by Scimed A Division Of Boston Scientific Corporation.
[15008220]
During a valvuloplasty procedure, the balloon detached from the shaft. All pieces were retrieved. Pt status is listed as "ok".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000060-1997-00013 |
| MDR Report Key | 124611 |
| Report Source | 05,07 |
| Date Received | 1997-10-03 |
| Date of Report | 1997-09-10 |
| Date of Event | 1997-09-08 |
| Date Facility Aware | 1997-09-08 |
| Report Date | 1997-09-10 |
| Date Mfgr Received | 1997-09-10 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 1997-10-07 |
| 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 | 1997-10-03 |
| Returned To Mfg | 1997-09-11 |
| Model Number | OWENS LO-PROFILE |
| Catalog Number | 2617 |
| Lot Number | 567546 |
| ID Number | NA |
| Device Expiration Date | 1996-03-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 121998 |
| Manufacturer | SCIMED A DIVISION 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 LO-PROFIL |
| Baseline Catalog No | 2617 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-10-03 |