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

Model Number M00562321

Device Problem Failure to Cut (2587)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Imdrf device code a050702 captures the reportable event of loop cutting issues.

Event Description

It was reported to boston scientific corporation that a captivator medium oval stiff snare was used during a polypectomy procedure performed on (b)(6) 2023.During the procedure, the snare could not be tightened when closed.The root of the polyp could not be cut from the intestinal wall and it was reported that the wound surface was large.There was no intervention required to address the bleeding and the bleeding resolved on its own.The procedure was completed with a similar captivator medium oval.The patient's current condition post procedure was reported to be stable.

• 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: 17224397
• MDR Text Key: 318238642
• Report Number: 3005099803-2023-03357
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 06/29/2023

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 Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0029988909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 68 KG