MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2000-10-10 for VALVULOPLASTY CATHETER C/L 20-5.5/9/110 H74923160 manufactured by Boston Scientific Corporation, Ireland, Ltd..
[168493]
It was reported that during a valvuloplasty procedure, the pigtail portion of the catheter broke off. Pt status is listed as "okay".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000089-2000-00206 |
| MDR Report Key | 299646 |
| Report Source | 01,05,07 |
| Date Received | 2000-10-10 |
| Date of Report | 2000-08-16 |
| Date of Event | 2000-06-22 |
| Date Facility Aware | 2000-06-22 |
| Report Date | 2000-08-16 |
| Date Mfgr Received | 2000-08-16 |
| Device Manufacturer Date | 1998-05-01 |
| Date Added to Maude | 2000-10-13 |
| 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 |
| Manufacturer Contact | KRISTIN JOHNSON, MS B230 |
| Manufacturer Street | ONE SCIMED PL |
| Manufacturer City | MAPLE GROVE MN 553111566 |
| Manufacturer Country | US |
| Manufacturer Postal | 553111566 |
| Manufacturer Phone | 7634941450 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2000-10-10 |
| Returned To Mfg | 2000-09-05 |
| Model Number | C/L 20-5.5/9/110 |
| Catalog Number | H74923160 |
| Lot Number | 1056491 |
| ID Number | NA |
| Device Expiration Date | 2000-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 25 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 290043 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION, IRELAND, LTD. |
| Manufacturer Address | BALLYBRIT BUSINESS PARK GALWAY EI |
| Baseline Brand Name | OWENS VALVULOPLASTY BALLOON DILATION CATHETER |
| Baseline Generic Name | VALVULOPLASTY BALLOON CATHETER |
| Baseline Model No | C/L 20-5.5/9/11 |
| Baseline Catalog No | H74923160 |
| Baseline ID | NA |
| Baseline Device Family | VALVULOPLASTY BALLOON CATHETER |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-10-10 |