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

Model Number M00561291

Device Problems Failure to Cut (2587); Material Deformation (2976)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

Problem code: (b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon 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

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) 2022.It was reported that during the procedure and inside the patient, the snare would not cut through the tissue.When device was removed from the scope, it was kinked and cut wire was exposed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator extra large round stiff snare was received for analysis.Visual inspection of the returned device revealed that the wire was kinked and the working length was ripped, torn and kinked making it impossible to extend and retract the loop.The loop was partially moved from the working length and it was in good condition.Additionally, the working length was separated from the strain relief which showed evidence of flaring.Functional inspection could not be completed due to the condition of the device.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported event of "loop failure to cut" was confirmed.It is probable that the damages found could induce cutting problems.The reported event of "loop kinked" was not confirmed since the loop was found to be in good condition.The product record review confirmed that there was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Upon product analysis it was observed that the wire was kinked and the working length was ripped, torn and kinked.These types of problems may result from the 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 events.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 was 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.

Event Description

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), 2022.It was reported that during the procedure and inside the patient, the snare would not cut through the tissue.When device was removed from the scope, it was kinked and cut wire was exposed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR II
• 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: 13656080
• MDR Text Key: 288108131
• Report Number: 3005099803-2022-00943
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0027311934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1