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

Model Number M00562402

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 # 3005099803-2021-04531 for the associated device information.It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, an oval snare was unable to cauterize a very large rectal polyp.The snare became embedded in the polyp and was cut to remove.This occurred with two snares from the same lot number.Two different cautery machines were tried and the snares did not work with either.The snares were tested before placing them around the polyp and worked at that time.Reportedly, the snares were securely attached to the active cord and there were no visible issues noted with the cautery pins.The procedure was completed with a different device and taking the polyp in small pieces.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code a150280 captures the reportable event of loop embedded in patient's tissue.Problem code a050702 captures the reportable event of polyp resecting issue.Block h10: (product investigation) one captiflex snare was received for analysis.Visual inspection of the returned device revealed that the working length and wire were cut off in the proximal side and the working length and the wire were kinked.No problems were noted with the cautery pin.Microscopic inspection found that the working length and wire were cut off in the proximal side.The reported problems of "failure to deliver energy," "loop failure to cut" and "loop entrapment of device or device component" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Also, the device was returned with the sheath and wire cut off making impossible to perform any test.In addition, the working length was kinked.It was reported that the snare was embedded in the polyp and intervention was required.Upon device analysis it was noted that the working length and wire were cut off which matches with the reported event that states the device was cut.The user may have applied excessive force trying to remove the device from the polyp resulting in the device damage.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This code was selected as the problem cannot be confirmed based on the device condition of the returned device that made it impossible to perform any tests.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-04530 and 3005099803-2021-04531 for the associated device information.It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, an oval snare was unable to cauterize a very large rectal polyp.The snare became embedded in the polyp and was cut to remove.This occurred with two snares from the same lot number.Two different cautery machines were tried and the snares did not work with either.The snares were tested before placing them around the polyp and worked at that time.Reportedly, the snares were securely attached to the active cord and there were no visible issues noted with the cautery pins.The procedure was completed with a different device and taking the polyp in in small pieces.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12414884
• MDR Text Key: 269567470
• Report Number: 3005099803-2021-04530
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0027085177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention