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

Model Number M00561221

Device Problems Failure to Cut (2587); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator ii snare was used in the colon during a polypectomy procedure performed on (b)(6) 2024.During the procedure and inside the patient, the snare could not remove the polyp, and the sheath was fractured.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

Manufacturer Narrative

Block e1: the reported health care facility is (b)(6).Block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.

Event Description

It was reported to boston scientific corporation that a captivator ii snare was used in the colon during a polypectomy procedure performed on (b)(6) 2024.During the procedure and inside the patient, the snare could not remove the polyp, and the sheath was fractured.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Additional information received on february 29, 2024.The snare was used to remove a 6cm polyp.The working length was separated.The snare was securely attached to the active cord.No problems with the cautery pin.

Manufacturer Narrative

Block e1: (b)(6) block h6: imdrf device code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results one captivator ii snare was received for analysis.Visual analysis of the returned device revealed the working length was detached and the flare was kinked under microscopic inspection.Therefore, functional testing was not performed due to the condition of the device.No other device problems were noted.The reported complaint of loop failure to cut was unable to be confirmed since the device analysis revealed the working length was detached and the flare was kinked.Due to this condition, it was unable to perform a functional inspection to verify if the loop was able to extend and retract correctly.According to the evidence, one of the possibilities that could have happened is that as part of the device manipulation during preparation an excess of force was applied in order to get the device out of the package, causing the working length to get detached.Also, possibly during its actuation during the testing the analyzed damages could have been caused.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected as the reported event of loop failure to cut could not be confirmed through product analysis.Block h11: block a2 (age at time of event) has been corrected.Blocks a1 (patient identifier), a2 (date of birth, rfb date of birth) b5, e1 (initial reporter last name and initial reporter email) have been updated based on the additional information received on february 29, 2024.

• 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: 18664046
• MDR Text Key: 334837930
• Report Number: 3005099803-2024-00307
• 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,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 0032200964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2023
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 73 KG