MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2005-10-11 for CAPIO RP * 832-101 manufactured by Boston Scientific Corp, A Division Of Boston Scientific Corp..
[433296]
It was reported that during a therapeutic prostate procedure this capio successfully placed the first suture. Then the second suture could not be placed because the needle carrier had broken off when it was being loaded. The procedure was completed successfully with no pt complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000111-2005-00025 |
| MDR Report Key | 642848 |
| Report Source | 01,05,06,07 |
| Date Received | 2005-10-11 |
| Date of Report | 2005-09-29 |
| Date of Event | 2005-09-29 |
| Date Mfgr Received | 2005-10-04 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2005-10-27 |
| 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 | 3 |
| 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 CORPORATION |
| 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 |
| Generic Name | SUTURING SYSTEM |
| Product Code | MCZ |
| Date Received | 2005-10-11 |
| Model Number | * |
| Catalog Number | 832-101 |
| Lot Number | 7932460 |
| ID Number | * |
| Device Expiration Date | 2008-08-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 632363 |
| Manufacturer | BOSTON SCIENTIFIC CORP, A DIVISION OF BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 8600 N.W. 41ST STREET 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 | 2005-10-11 |