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 2020-02-19 for CAPTIVATOR II M00561291 6129 manufactured by Boston Scientific Corporation.
[188651626]
(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 supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[188651627]
It was reported to boston scientific corporation that a captivator extra large round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, a 33mm captivator snare was inserted to remove a large cecal polyp. The physician was able to place the initial snare around the polyp and was in the process of trying to position the snare when it was noted that there was difficulty in closing the snare. When the snare finally did close, they were unable to use the cautery feature. Several attempts were made to manipulate the snare, all of which failed. It was this time the technician involved in the case noted that the sheath surrounding the snare had a slit located about 10cm from the handle and in order for the snare to close, the technician had to manipulate the wire with her finger to get it to close. At this time, both a surgeon and the medical director of the gi lab were notified and called into the room to obtain their opinions on how to proceed. It was finally decided that the snare wire itself was needed to be cut and then both the colon scope and the sheath would need to be removed leaving the snare wire in the patient. After both the scope and wire were removed, the scope was again inserted carefully trying not to drag the wire in with it. A pair of hemostats was attached to the end of the wire to prevent any issues. Once the scope was in proper position, a second 33mm captivator snare was inserted successfully and the polyp was removed in small pieces until the original snare wire was freed and then removed from the patient. There were no patient complications reported as a result of this event. The patient condition at the conclusion of the procedure was reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00495 |
| MDR Report Key | 9727048 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2018-02-27 |
| Date Added to Maude | 2020-02-19 |
| 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 II |
| Generic Name | SNARE, FLEXIBLE |
| Product Code | FDI |
| Date Received | 2020-02-19 |
| Model Number | M00561291 |
| Catalog Number | 6129 |
| Lot Number | 0021798806 |
| 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. Required No Informationntervention | 2020-02-19 |