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

Model Number	M00561191
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-25mm round stiff snare was used to remove a polyp in the intestinal tract during a removal of intestinal polyps procedure performed on (b)(6) 2021.During the procedure, the snare loop was fractured while removing the polyps.The procedure was completed using another captivator snare.There were no patient complications reported and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code a0401 captures the reported event of snare loop broken.Block h10: (product investigation): one captivator snare was received for analysis.Visual analysis of the returned device noted the loop was twisted and the working length was kinked.Functional evaluation of the returned device found that when the device was connected to the 10 inch loop fixture, it contracted and extended well even with the twisted snare loop.The reported event of "loop break" was not confirmed since it was found the device evaluation revealed that the loop was twisted.The product record review revealed no anomalies.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.An investigation into twisted snare loop revealed that the manufacturing method may have contributed to the problem.A correction was implemented to address the problem.It was confirmed that this device was manufactured prior to the correction.
Event or Problem Description
It was reported to boston scientific corporation that a captivator ii-25mm round stiff snare was used to remove a polyp in the intestinal tract during a removal of intestinal polyps procedure performed on (b)(6) 2021.During the procedure, the snare loop was fractured while removing the polyps.The procedure was completed using another captivator snare.There were no patient complications reported and the patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: CAPTIVATOR II
• 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: 13114347
• Report Number: 3005099803-2021-08011
• Device Sequence Number: 3510618
• Product Code: FDI
• UDI-Device Identifier: 08714729855934
• UDI-Public: 08714729855934
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133987
• 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): 03/01/2022

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: 06/30/2023
• Device Model Number: M00561191
• Device Catalogue Number: 6119
• Device Lot Number: 0025657379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2020
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 57 KG