MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-13 for CAPIO SUTURE DEVICE manufactured by Boston Scientific.
[45494628]
Patient was having a posterior urethroplasty performed. The surgeon was using a capio suture device with a capio suture which has a sh needle at one end of the suture with a separate 2. 5mm at the other end of 36 inch suture. The bullet became detached from the suturing device while in the patient. The surgeons were not able to retrieve the small bullet from the scar tissue area because of potential harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062327 |
| MDR Report Key | 5662231 |
| Date Received | 2016-05-13 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-04-28 |
| Date Added to Maude | 2016-05-18 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAPIO SUTURE DEVICE |
| Generic Name | CAPIO SUTURE DEVICE |
| Product Code | MFJ |
| Date Received | 2016-05-13 |
| Returned To Mfg | 2016-04-28 |
| Lot Number | 74A1500125 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-13 |