MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-19 for CAPIO OPEN ACESS 831-125 manufactured by Boston Scientific - Miami.
[558534]
It was reported that a patient underwent a pelvic floor reconstruction fixation procedure in 2006. It is believed that half of the metal needle carrier fractured while inside the patient. The physician was attempted to retrieve it but was not successful. The procedure was completed. The device was disposed of after use. Patient does not require any additional follow up due to this event and a full recovery is expected.
Patient Sequence No: 1, Text Type: D, B5
[7926480]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine if the device met specification. Should further relevant details become available, a supplemental medwatch report will be filed under the appropriate sequence number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000111-2006-00030 |
| MDR Report Key | 838793 |
| Report Source | 05,06 |
| Date Received | 2006-10-19 |
| Date of Report | 2006-09-23 |
| Date of Event | 2006-09-21 |
| Date Mfgr Received | 2006-09-23 |
| Date Added to Maude | 2007-04-19 |
| 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 | ROSE CARD |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834575 |
| 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 OPEN ACESS |
| Generic Name | SUTURE CAPTURING DEVICE |
| Product Code | MCZ |
| Date Received | 2006-10-19 |
| Model Number | NA |
| Catalog Number | 831-125 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826097 |
| Manufacturer | BOSTON SCIENTIFIC - MIAMI |
| Manufacturer Address | 8600 N.W. 41ST STREET MIAMI FL 331666202 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-19 |