MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-02 for CAPIO * 831-826 manufactured by Boston Scientific Corporation.
[4032932]
When the capio open access slim product was opened the product was described as flimsy. The working end of the product would not allow the suture to remain in the tissue. The suture would retract back into device tip. The suture would not release from the device. Three devices were opened, two of which were capio slim. The third device was the old design capio and if functioned properly. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3590681 |
| MDR Report Key | 3590681 |
| Date Received | 2014-01-02 |
| Date of Report | 2014-01-02 |
| Date of Event | 2013-12-27 |
| Report Date | 2014-01-02 |
| Date Reported to FDA | 2014-01-02 |
| Date Reported to Mfgr | 2014-01-24 |
| Date Added to Maude | 2014-01-24 |
| 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 | 3 |
| 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 | CAPIO |
| Generic Name | SUTURE CAPTURING DEVICE |
| Product Code | MFJ |
| Date Received | 2014-01-02 |
| Model Number | * |
| Catalog Number | 831-826 |
| Lot Number | 16024002 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE NATICK MA * * US * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-02 |