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

Model Number M00561221

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a 10mm captivator ii round stiff snare was used during an intestinal polypectomy procedure performed on (b)(6) 2023.During the procedure, when the package was opened prior to the procedure, the device was missing a snare at its tip, rendering it unusable.The procedure was completed with a similar captivator ii round stiff snare.There were no patient complications reported as a result of this event.Note: this event has been deemed a mdr- reportable event based on investigation results which revealed that the cautery pin was detached.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf component code g0405209 captures the reportable event of cautery pin detached.Block h10: (product investigation) the returned captivator snare was analyzed and a visual evaluation noted that the 2-in-1 connector was broken confirming the reported event as this would lead to a missing snare.No other device problems were noted.An investigation to address the broken 2-in-1 connector has been completed and solutions have been confirmed to be effective.The investigation identified that the root cause of the 2-in-1 connector break is that the notch in the 2-in-1 connector thread is behaving as a stress-raiser, causing a weak point in the connector when torque is applied.A change to the component was implemented (b)(6) 2022 to increase the thread length, and therefore eliminate the notch acting as a stress-raiser and causing the 2-in-1 active cord connector to break when torque is applied.The complaint device was manufactured january 13, 2022, prior to the implemented change.With all available information boston scientific concludes that the most probable cause of the event is manufacturing deficiency and was addressed by capa-00006316.

• 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: 17224469
• MDR Text Key: 318962825
• Report Number: 3005099803-2023-03445
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0028671432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 56 KG