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 2020-01-09 for CAPTIFLEX M00562402 6240-40 manufactured by Boston Scientific Corporation.
[174291724]
(b)(4). The device has not been received for analysis; 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
[174291725]
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used in the proximal transverse colon during a screening colonoscopy procedure on (b)(6) 2019. According to the complainant, during the procedure and inside the patient, a large target polyp was attempted to be removed, however, the snare would not progress completely through the "stiffer" target polyp. The physician was unable to loosen, withdraw or unwrap the snare from the target polyp even with the use of heat. The patient was tattooed at the location where the snare loop was embedded and they had to cut the snare loop leaving it inside the patient. A surgical removal was planned for the following week, but additional information received on (b)(6) 2020 confirmed that the patient passed the snare loop. The polyp will be removed via surgery at a later date. The patient condition following the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2019-06351 |
| MDR Report Key | 9568625 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-10 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-08-06 |
| 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 | CAPTIFLEX |
| Generic Name | SNARE, FLEXIBLE |
| Product Code | FDI |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2020-01-20 |
| Model Number | M00562402 |
| Catalog Number | 6240-40 |
| Lot Number | 0024223879 |
| 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 |