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

Model Number	M00562341
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A photo was provided by the physician and as per media inspection it was noted that the cautery pin was detached.This damage was likely what the customer perceived as "handle break." the reported event was confirmed.Based on the information available and the analysis performed, the most probable root cause for this problem is design inadequate for purpose since there were problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the handle of the snare was broken on first use as they attempted to ensnare it around a polyp.Reportedly, there were no problems noted upon opening the package.In the photo provided, the handle appeared broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the cautery pin was detached.

• Brand Name: CAPTIVATOR
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12586122
• Report Number: 3005099803-2021-05113
• Device Sequence Number: 3787884
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0026909744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1