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

Model Number M00562321

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

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event 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.

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 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.

Manufacturer Narrative

Block e1 (initial reporter address 1): (b)(6).

• 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: 17086023
• MDR Text Key: 316806074
• Report Number: 3005099803-2023-03077
• 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,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• 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: 0029527460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• 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: 46 YR
• Patient Sex: Female