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

Model Number M00561311

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Failure to Cut (2587)

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

Event Date 05/01/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an injection gold probe needle was used during a gastroscopy procedure performed on an unknown date.It was reported to boston scientific corporation that a 30mm captivator large oval med stiff was used during a colonoscopy with polypectomy performed on an unknown date.Erbe plate was attached to the patient prior to the procedure using the erbe v102005 diathermy machine set to left colon polypectomy.The polyp was raised in accordance with (b)(6) protocols.A small piece of the polyp was initially removed with the snare.On the second attempt, the snare loop was embedded within the polyp and would not open to be removed.Several attempts to open the snare were unsuccessful.The list consultant decided to abandon the procedure and cut the snare at the patient's anus, and the patient was transferred to the qeuh for bowel surgery.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf impact code f19 captures the reportable event of surgical intervention imdrf device code a050702 captures the reportable event of loop cutting issue.

• 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: 17113552
• MDR Text Key: 317168537
• Report Number: 3005099803-2023-02980
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: 08714729019251
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2024
• Device Model Number: M00561311
• Device Catalogue Number: 6131
• Device Lot Number: 0026954454
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention