MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-19 for BYCEP PC "7" * REL #6251 manufactured by Boston Scientific Corp..
[84884]
Biopsy forceps used during right heart catheterization with biopsy, tore tissue instead of cutting. 10 times usual amount taken. Pt had heart arrythmias and had to be medicated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013876 |
| MDR Report Key | 170123 |
| Date Received | 1998-05-19 |
| Date of Report | 1998-05-17 |
| Date of Event | 1998-05-13 |
| Date Added to Maude | 1998-06-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BYCEP PC "7" |
| Generic Name | BIOPSY FORCEPS-DISPOSABLE |
| Product Code | DWZ |
| Date Received | 1998-05-19 |
| Model Number | * |
| Catalog Number | REL #6251 |
| Lot Number | 606086 |
| ID Number | * |
| Device Expiration Date | 1999-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 165481 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 135 FORBES BLVD. MANSFIELD MA 02048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-19 |