MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-04 for COLPASSIST manufactured by Boston Scientific Corporation.
[132089392]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(6). The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[132089393]
It was reported to boston scientific corporation that a y-mesh was implanted during a robotic sacrocolpopexy procedure performed on (b)(6) 2018. According to the complainant, during the procedure, while suturing the y-mesh to the vaginal wall, the physician slightly nicked the mesh. It was a small tear from pulling using the robotic arm. Subsequently, the physician put a suture very close to the small tear to seemingly support the small mesh defect. Reportedly, this procedure was difficult as the patient's anatomy was unique due to a prior abdominal surgery. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-62442 |
| MDR Report Key | 8217507 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-12-07 |
| Date Mfgr Received | 2018-12-07 |
| Date Added to Maude | 2019-01-04 |
| 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 | MS. CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | PROXY BIOMEDICAL |
| Manufacturer Street | COILLEACH |
| Manufacturer City | SPIDDAL, CO GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLPASSIST |
| Generic Name | MESH, SURGICAL, SYNTHETIC |
| Product Code | KOH |
| Date Received | 2019-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |