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 2020-02-06 for CAPIO SLIM M0068318250 831-825 manufactured by Boston Scientific Corporation.
[188520907]
Date of event was approximated to (b)(6) 2019 as the event reportedly occurred in (b)(6) 2019 and no specific event date was reported. The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). The complaint device is not expected to 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. The voluntary user medwatch number is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188520908]
It was reported to boston scientific corporation that a capio slim device was used during a total vaginal hysterectomy, posterior repair, sacrospinous ligament, vaginal vault fixation procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the device "needle barb" broke off. There was no patient harm noted. The failure mode is unclear, and the event description most likely suggests that the carrier broke off. It is unknown if the event occurred inside the patient and if/how the detached part was removed from the patient. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00273 |
| MDR Report Key | 9679621 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-02-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROLE MORLEY |
| Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834015 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPIO SLIM |
| Generic Name | HOLDER, NEEDLE, GASTROENTEROLOGIC |
| Product Code | FHQ |
| Date Received | 2020-02-06 |
| Model Number | M0068318250 |
| Catalog Number | 831-825 |
| 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 | 1. Other | 2020-02-06 |