MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 1998-08-17 for OWENS VALVULOPLASTY CATHETER VACA 2 LUMEN OWENS SOFT EXTRUS H74992150 manufactured by Scimed/ A Division Of Boston Scientific Corp..
[98978]
It was reported that during a valvuloplasty procedure, the balloon ruptured. No pt injury or complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000060-1998-00044 |
| MDR Report Key | 183192 |
| Report Source | 01,06,07 |
| Date Received | 1998-08-17 |
| Date of Report | 1998-07-02 |
| Date of Event | 1997-10-21 |
| Date Facility Aware | 1997-10-21 |
| Report Date | 1998-07-02 |
| Date Mfgr Received | 1998-07-02 |
| Date Added to Maude | 1998-08-21 |
| 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 | OWENS VALVULOPLASTY CATHETER |
| Generic Name | VALVULOPLASTY CATHETER |
| Product Code | MAD |
| Date Received | 1998-08-17 |
| Returned To Mfg | 1998-07-14 |
| Model Number | VACA 2 LUMEN OWENS SOFT EXTRUS |
| Catalog Number | H74992150 |
| Lot Number | 561943 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 178109 |
| Manufacturer | SCIMED/ A DIVISION OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 6655 WEDGWOOD ROAD MAPLE GROVE MN 55311 US |
| Baseline Brand Name | OWENS VALVULOPLASTY BALLOON DILATATION CATHETER |
| Baseline Generic Name | VALVULOPLASTY BALLOON CATHETER |
| Baseline Model No | VACA 2 LUMEN OW |
| Baseline Catalog No | H74921010 |
| Baseline ID | NA |
| Baseline Device Family | VALVULOPLASTY BALLOON CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K896520 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-08-17 |