MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-06-22 for CAPIO RP SUTURING DEVICE 832-101 manufactured by Boston Scientific - Miami.
[454027]
A pt underwent a radical prostatectomy procedure in 2003. After the procedure was successfully completed internal bleeding occurred. Pt was treated for blood loss and internal bleeding. Physician irrigated clots out. No other info is available.
Patient Sequence No: 1, Text Type: D, B5
[7845837]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and co is not able to determine if the device met specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000111-2006-00020 |
| MDR Report Key | 728347 |
| Report Source | 05,06 |
| Date Received | 2006-06-22 |
| Date of Report | 2004-01-21 |
| Date of Event | 2003-11-03 |
| Date Mfgr Received | 2004-01-27 |
| Date Added to Maude | 2006-06-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | BOSTON SCIENTIFIC - MIAMI |
| Manufacturer Street | 8600 N.W. 41ST STREET |
| Manufacturer City | MIAMI FL 33166620 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33166 6202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO RP SUTURING DEVICE |
| Generic Name | SUTURE CAPTURING DEVICE |
| Product Code | MCZ |
| Date Received | 2006-06-22 |
| Model Number | NA |
| Catalog Number | 832-101 |
| Lot Number | UNK |
| ID Number | NA |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 716643 |
| Manufacturer | BOSTON SCIENTIFIC - MIAMI |
| Manufacturer Address | 8600 N.W. 41ST ST MIAMI FL 331666202 US |
| Baseline Brand Name | CAPIO RP |
| Baseline Generic Name | SUTURING SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 832-101 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-06-22 |