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

Model Number M00561291

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 extra large round stiff snare was used in the ascending colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, upon first pass using the snare, a 5 cm large piece of the polyp was grasped.Nothing seemed to happen whenever cauterization was applied.Reportedly, the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin.As the physician kept trying to cut the target polyp, they noticed that the sheath was kinking when closing force was applied.The device failed to cut the target polyp so the operator attempted to remove the snare.However, the device was stuck in the polyp and was difficult to remove.The physician wiggled it around for a little while and the snare finally came loose.The grounding pads were replaced in the patient and the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 1212 captures the reportable event of snare loop embedded in patient tissue.Block h10: investigation results a captivator extra large round stiff snare was received for analysis.Functional and continuity tests were performed and they were found within specifications.Based on the information available and the analysis performed, the most probable root cause of the reported event is no problem detected, since the reported problem cannot be confirmed.Visual analysis of the returned device revealed that the device has a kink on distal section of the catheter and the loop was bent.As per event description, the snare got stuck in the polyp and the device had signs of usage and bend on the loop resulting to entrapment of the loop.Moreover, it is possible that operational factors, such as user technique/handling during usage, contributed to the observed kink on the working length and bend of the loop.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure.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 in the ascending colon during a colonoscopy with polypectomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, upon first pass using the snare, a 5cm large piece of the polyp was grasped.Nothing seemed to happen whenever cauterization was applied.Reportedly, the snare was securely attached to the active cord and there were no visible issues noted with the cautery pin.As the physician kept trying to cut the target polyp, they noticed that the sheath was kinking when closing force was applied.The device failed to cut the target polyp so the operator attempted to remove the snare.However, the device was stuck in the polyp and was difficult to remove.The physician wiggled it around for a little while and the snare finally came loose.The grounding pads were replaced in the patient and the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8864386
• MDR Text Key: 153395915
• Report Number: 3005099803-2019-03806
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2021
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0022340287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR