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

Model Number M00562340

Device Problem Failure to Cut (2587)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that a captivator snare was used for polyp removal in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the device could not cut with both hot and cold snaring.The procedure was completed with another captivator snare.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 snare loop cutting problems.Block h10: one captivator - snares was returned for analysis.The device was carefully inspected, and no problems were found.A functional evaluation noted that it was extended and retracted in the 10- inch loop fixture and the loop could extend and retract well.Besides that, an electrical test was performed, and the device was found within specification.No other device problems were noted.The reported complaint of loop failure to cut was unable to be confirmed since the device returned without any problems on it, and a functional and electrical inspections were performed, and the device was found within specification.It is important to mention that the device cannot be functionally tested by emulating the anatomical/procedural factors encountered during the procedure.The analysis of the available information, product analysis of the returned device and product record review did not identify any evidence of either the alleged issues or any defect on the device.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the reported complaint cannot be confirmed.

Event Description

It was reported to boston scientific corporation that a captivator snare was used for polyp removal in the colon during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, the device could not cut with both hot and cold snaring.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18747279
• MDR Text Key: 335870871
• Report Number: 3005099803-2024-00587
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729747871
• UDI-Public: 08714729747871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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: 07/14/2022
• Device Model Number: M00562340
• Device Catalogue Number: 6234
• Device Lot Number: 0024110626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• 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