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

Model Number M00561233

Device Problem Retraction Problem (1536)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a 15mm captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6), 2023.During the procedure, the device was very stiff then closed almost cold snaring a thick stalk.The procedure was completed with a similar captivator ii snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0510 captures the reportable event of loop retracted suddenly.

• 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: 17645751
• MDR Text Key: 322217604
• Report Number: 3005099803-2023-04472
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861348
• UDI-Public: 08714729861348
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561233
• Device Catalogue Number: 50297
• Device Lot Number: 0031704828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• 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