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

Model Number M00562340

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587); Material Deformation (2976); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 10/28/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove polyps in the sigmoid colon during a colonoscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare loop was placed around the head of the polyp and the physician tried to hot snare off the polyp, but no energy was produced.The snare became embedded in the polyp.Many attempts of opening and closing the snare were performed but the snare remained embedded.The braiding around the snare unraveled and exposed the wire.The physician loaded hemostats through the working channel and used those to pry the snare off the polyp.The procedure was completed with clips.There were no patient complications reported as a result of this event.Clips were used to complete the procedure and the patient was sent for surgery.It was reported that the patient needed surgery anyways and it was not related to the snare.

Manufacturer Narrative

(b)(4).

• 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 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: 15848009
• MDR Text Key: 304174361
• Report Number: 3005099803-2022-06762
• 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: K941750
• 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
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562340
• Device Catalogue Number: 6234
• Device Lot Number: 0029666744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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
• Patient Outcome(s): Required Intervention