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

Model Number M00561232

Device Problem Failure to Cut (2587)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of loop cutting issues.

Event Description

It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used during a colonoscopy procedure performed on july 31, 2023.During the procedure, the physician encountered a problem with the cautery while attempting to remove a pedunculated polyp in the sigmoid colon.This resulted in the patient experiencing a hematoma and bleeding, which required the administration of an epinephrine injection and the application of three clips.Notably, the same snare had been used successfully earlier during a hot polypectomy procedure in the transverse colon, and all necessary precautions had been taken.The grounding pad was intact and connected, the snare was properly connected, and the pedal was functioning correctly.After careful evaluation, the medical team concluded that the snare malfunctioned when the cautery was being used for the second time.The procedure was completed with the original device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a050702 captures the reportable event of unable to cut.Block h10 investigation results: one captivator snare was received for analysis.Visual analysis of the returned device found no device problems.Functional analysis of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended well.Electrical analysis was also performed and the device's electrical resistance was within specification.The reported event of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to the anatomical/procedural factors encountered during the procedure.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.Device analysis found no problems with the device during visual, functional and electrical test.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected.This code was selected since the reported event could not be confirmed.

Event Description

It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the physician encountered a problem with the cautery while attempting to remove a pedunculated polyp in the sigmoid colon.This resulted in the patient experiencing a hematoma and bleeding, which required the administration of an epinephrine injection and the application of three clips.Notably, the same snare had been used successfully earlier during a hot polypectomy procedure in the transverse colon, and all necessary precautions had been taken.The grounding pad was intact and connected, the snare was properly connected, and the pedal was functioning correctly.After careful evaluation, the medical team concluded that the snare malfunctioned when the cautery was being used for the second time.The procedure was completed with the original device.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: 17602437
• MDR Text Key: 321725392
• Report Number: 3005099803-2023-04406
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861331
• UDI-Public: 08714729861331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561232
• Device Catalogue Number: 50296
• Device Lot Number: 0031771304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• 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