MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-09 for CAPTIVATOR COLD SINGLE-USE SNARE M00561100 6110 manufactured by Boston Scientific Corporation.
[174508496]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplement mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[174508497]
It was reported to boston scientific corporation that a 10mm round cold snare was used in the colon during a polypectomy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the snare loop came off when the nurse closed the snare on the polyp. It was the second polyp they had removed with this snare. The physician used a biopsy forceps to remove the detached snare loop and also cleaned off the rest of the polyp with the biopsy forceps. The procedure was completed with a different device. There were no patient complication reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06349 |
| MDR Report Key | 9570006 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-10-30 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Returned To Mfg | 2020-01-08 |
| Model Number | M00561100 |
| Catalog Number | 6110 |
| Lot Number | 0024685199 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2020-01-09 |