MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-16 for MANSFIELD BYCEP #6251 UNK manufactured by Mansfield Boston Scientific Corp..
[21400632]
Pt underwent endomyocardial biopsy. A disposable bioptome was used to obtain myocardial biopsy specimens. The bioptome was unable to retracted. It perforated the superior vena cava. Atrial pacing wire extraction sheaths were used to extract the bioptome. The pt remained hemodynamically stable but was kept overnight for observation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 46012 |
| MDR Report Key | 46012 |
| Date Received | 1996-08-16 |
| Date of Report | 1996-04-10 |
| Date of Event | 1996-02-01 |
| Date Added to Maude | 1996-11-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANSFIELD |
| Generic Name | DISPOSABLE BIOPTOME |
| Product Code | DWZ |
| Date Received | 1996-08-16 |
| Returned To Mfg | 1996-02-23 |
| Model Number | BYCEP #6251 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 46863 |
| Manufacturer | MANSFIELD BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 610 PLEASANT ST WATERTOWN MA 02172 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-08-16 |