MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-22 for MANSFIELD BOSTON SCIENTIFIC CORP. VACAS/25 3/10/100 2108 manufactured by Boston Scientific Corp..
[184964]
Valvuloplasty balloon inflated at 1 atm, balloon ruptured on first inflation. Product labeled rated to 2. 7 atm. Product returned to mfr 9/22/99.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017226 |
| MDR Report Key | 242053 |
| Date Received | 1999-09-22 |
| Date of Report | 1999-09-22 |
| Date of Event | 1999-09-17 |
| Date Added to Maude | 1999-09-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANSFIELD BOSTON SCIENTIFIC CORP. |
| Generic Name | BALLOON DIALATION CATHETER |
| Product Code | MAD |
| Date Received | 1999-09-22 |
| Returned To Mfg | 1999-09-22 |
| Model Number | VACAS/25 3/10/100 |
| Catalog Number | 2108 |
| Lot Number | 596219 |
| ID Number | NA |
| Device Expiration Date | 1999-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 234513 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PL. NATICK MA 017601537 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-09-22 |