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

Model Number M00562340

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Mechanical Problem (1384); Failure to Cut (2587); Material Twisted/Bent (2981)

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

Event Date 04/05/2021

Event Type  malfunction  

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

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was to be used to remove a 27mm target polyp in the colon during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, they captured the polyp but when they went to apply cautery to cut the tissue, there was no current so the snare would not cut through the tissue.They stated that the wire by the handle buckled and the snare loop became embedded in the patient's tissue which would not allow the loop to open and release the tissue.They indicated that they continued to manipulate the device and finally able to get it loose after almost an hour.The snare was securely attached to the active cord and no visible issue was noted with the cautery pin.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was to be used to remove a 27mm target polyp in the colon during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, they captured the polyp but when they went to apply cautery to cut the tissue, there was no current so the snare would not cut through the tissue.They stated that the wire by the handle buckled and the snare loop became embedded in the patient's tissue which would not allow the loop to open and release the tissue.They indicated that they continued to manipulate the device and finally able to get it loose after almost an hour.The snare was securely attached to the active cord and no visible issue was noted with the cautery pin.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting issue.Problem code a150208 captures the reportable event of snare loop entrapment.Block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed that the wire was kinked and was exiting the working length, and the working length itself was ripped, torn and kinked making it impossible to extend and retract the loop.Continuity test was performed and the device passed, indicating a proper connection.No other issues were noted.The reported complaint of loop failure to extend was confirmed since the analysis of the device found the wire was kinked and was exiting the working length, and the working length was ripped, torn and kinked making it impossible to extend and retract the loop.The reported complaint of device failure to deliver energy was unable to be confirmed since no issues were noted with the electrical device testing during continuity test upon return.The reported complaint of handle cannula bent was unable to be confirmed since the cannula was not bent upon return.The reported events of loop entrapment of device or device component and loop failure to cut were unable to be confirmed, since it is most likely due to anatomical or procedural factors encountered during the procedure that the device performance was limited.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Upon product analysis it was observed that the wire was kinked, also it was found exiting the working length and the working length was ripped, torn and kinked making impossible to extend and retract the loop.These types of failures could get damage during its manipulation.Most likely procedural factors as handling of the device, the technique used by the physician during initial use, set-up, power-up, or shortly thereafter could have affected its performance and its intended purpose, leading to the reported event.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.This is defined as the adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11761617
• MDR Text Key: 248706762
• Report Number: 3005099803-2021-01969
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729747871
• UDI-Public: 08714729747871
• Combination Product (y/n): N
• PMA/PMN Number: K941750
• 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: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2023
• Device Model Number: M00562340
• Device Catalogue Number: 6234
• Device Lot Number: 0026153134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1