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

Model Number	M00562321
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Cut (2587)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium oval stiff snare was used during a polypectomy procedure performed on an (b)(6) 2023.During the gastric polyp resection procedure in the ascending colon, the medical team encountered difficulty in using the captivator single-use polypectomy snares due to its small ring size.After the device was opened, it was observed to be in a strip shape.Following the cold incision, the wound began to bleed profusely and could not be stopped with irrigation.The bleeding was eventually stopped by the application of a clip to the wound and the procedure was completed with a similar captivator medium oval stiff snare.It was not reported if there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter address 1) (b)(6); block h6: imdrf device code a050702 captures the reportable event of loop cutting issues.
Event or Problem 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 gastric polyp resection procedure in the ascending colon, the medical team encountered difficulty in using the captivator single-use polypectomy snares due to its small ring size.After the device was opened, it was observed to be in a strip shape.Following the cold incision, the wound began to bleed profusely and could not be stopped with irrigation.The bleeding was eventually stopped by the application of a clip to the wound and the procedure was completed with a similar captivator medium oval stiff snare.It was not reported if there were no patient complications reported as a result of this event.Per additional information received on july 12, 2023, it was reported that cold incision was performed to resect a 1cm polyp, even though the snare loop did not fully extend, and it was the original device that was used to complete the procedure.
Additional Manufacturer Narrative
Block e1 (initial reporter address 1): (b)(6).

• Brand Name: CAPTIVATOR
• Common Device Name: 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: 17086023
• Report Number: 3005099803-2023-03077
• Device Sequence Number: 6089021
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2025
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0029527460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female