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 2018-11-19 for CAPTIVATOR COLD SINGLE-USE SNARE M00561101 manufactured by Boston Scientific Corporation.
[127565918]
(date of event): date of event was approximated to be (b)(6) 2018 as no 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). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[127565919]
It was reported to boston scientific corporation that a captivator round cold snare was to be used in a procedure on an unknown date. According to the complainant, during the procedure, when the snare loop was extended, the metal grommet extended out of the sheath. When the nurse or the technician was trying to close their hand to cut the tissue, instead of having a smooth cutting process, the grommet hung up on the sheath and when enough force was exerted on the handle, the snare loop retracted suddenly/unexpectedly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-61431 |
| MDR Report Key | 8084424 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-22 |
| Date Added to Maude | 2018-11-19 |
| 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 | 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 DE COSTA RICA S.R.L. |
| Manufacturer Street | 2546 CALLE PRIMERA PROPARK, COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTIVATOR COLD SINGLE-USE SNARE |
| Generic Name | SNARE, NON-ELECTRICAL |
| Product Code | FGX |
| Date Received | 2018-11-19 |
| Model Number | M00561101 |
| 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 | 2018-11-19 |