MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-24 for OWENS VALVULOPLASTY BALLOON DILATATION CATHETER 2617 manufactured by Scimed Life Systems A Div Of Boston Scientific Corp..
[20893606]
It was reported that a balloon detached from the catheter shaft during preparation before the procedure. There was no pt contact. The procedure was rescheduled. The device was returned, evaluated and retained by this mfr. The engineering eval indicated the balloon was detached from the shaft at the proximal end of the proximal sleeve. The area of separation appears to be smooth and there is no evidence of shaft elongation. The shaft was supple and flexible. No cause could be determined for this balloon/catheter separation based on co's aeval or follow up info obtained. No other complaints on this lot number have rec'd to date. Co this to be an isolated incident. All catheters are flex tested to ensure bond integrity during co mfg process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220076-1996-00008 |
| MDR Report Key | 45389 |
| Report Source | 05,06 |
| Date Received | 1996-10-24 |
| Date of Report | 1996-09-24 |
| Date of Event | 1996-09-24 |
| Date Mfgr Received | 1996-09-25 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 1996-10-31 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OWENS VALVULOPLASTY BALLOON DILATATION CATHETER |
| Generic Name | VALVULOPLASTY BAL CATH |
| Product Code | MAD |
| Date Received | 1996-10-24 |
| Model Number | NA |
| Catalog Number | 2617 |
| Lot Number | 569520 |
| ID Number | NA |
| Device Expiration Date | 1998-04-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 46273 |
| Manufacturer | SCIMED LIFE SYSTEMS A DIV OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 135 FORBES BLVD MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-24 |