MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIFLEX SNARE, FLEXIBLE

Model Number M00562401

Device Problems Break (1069); Entrapment of Device (1212); Failure to Cut (2587); Material Twisted/Bent (2981)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Tissue Damage (2104); No Code Available (3191)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Problem code 3191 no code available however relates to the reportable event of surgery. Problem code 2587 captures the reportable event of loop failure to cut. Problem code 1212 captures the reportable event of entrapment of device. Problem code 2104 captures the reportable event of tissue damage. Problem code 2001 captures the reportable event of perforation. Problem code 1888 captures the reportable event of hemorrhage. 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 medwatch will be filed.

Event Description

Note: this report pertains to one of two devices used during the same procedure. Refer to manufacturer report # 3005099803-2020-04816 and 3005099803-2020-04817 for the associated device information. It was reported to boston scientific corporation that two captiflex medium oval flexible snares were used during a colonoscopy with polypectomy procedure performed on (b)(6) 2020. According to the complainant, during the procedure, a six (6) cm pedunculate polyp was partially removed with the first snare using cautery over a saline pillow in the sigmoid colon. The first snare could not cut through the entire polyp due to thickness and size of the polyp stalk. The device became embedded in the polyp tissue and could not be retrieved in a normal fashion. The scope was removed from the patient after the proximal lock of the snare was cut using wire cutter. Then the sheath of snare was removed and a second snare was used in an attempt to retrieve the embedded snare and remove the remaining polyp. After few attempts, it was decided to call off the procedure and send the patient to surgery for the removal of the remaining snare and polyp and also to repair the perforation and hemorrhage. Reportedly, both snares were bent and broken at the handle. The embedded snare was successfully removed surgically however the patient's current condition is unavailable.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10717898
• MDR Text Key: 212512431
• Report Number: 3005099803-2020-04817
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0024873082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/22/2020 Patient Sequence Number: 1