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

Model Number M00562401

Device Problems Break (1069); 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

(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 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.

Manufacturer Narrative

Block h6: 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 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.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned." block h10: 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.Block h11: block b5 has been updated with the additional information received on october 27, 2020.Blocks h6 and h10 have been updated based on the investigation closure for device not returned.

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 since the snare wire was bent at the handle and was broken from the handle due to thickness and size or 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 using wire cutter.Then the sheath of snare was removed and a second snare was used to retrieve it and tried to 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.The embedded snare was successfully removed surgically however the patient's current condition is unavailable.According to the complainant, the perforation was due to the snare not cutting through the polyp and being embedded in the polyp.The wire did not break until they broke it to removed the polyp; the problem was it would not cut through the polyp.No visible fractures found at the handle.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10718271
• MDR Text Key: 212521861
• Report Number: 3005099803-2020-04816
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: 08714729019411
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: Health Professional
• Device Expiration Date: 12/03/2022
• Device Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0024873082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention