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

Model Number M00561241

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Medical device code a0501 captures the reportable event of cautery pin detached.

Event Description

It was reported to boston scientific corporation that a captivator round stiff snare was prepared for use during a procedure performed on (b)(6) 2023.During preparation when the device was tested, it was noted that there was an active cord connector connection problem.Upon inspection, the cautery pin was detached/broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device code a0501 captures the reportable event of cautery pin detached.Block h10 investigation results: a captivator round stiff snare was received for analysis.Visual and microscopic analysis of the returned device revealed that one measure of the 2 in 1 pin was out of specification.During the product analysis, the device was connected with three different cables.The bsi cable had connected well, the device was plugged with non-bsi active cord (conmed and erbe) and the cable also connected; however, no strong force was needed to remove it.Additionally, the 2-1 connector is correctly attached.No other problems were noted.The reported complaint of cautery pin detachment of device or device component could not be confirmed since the 2-1 connector was correctly attached.Based on the information available and the device analysis performed, it was noted that one dimension was not according to the 2 in 1 drawing, therefore, the most probable root cause for the reported complaint is manufacturing deficiency.Capa-00007233 was opened to investigate the issue between the interaction with 2 in 1 connector and the active cord, and issues reported in multiple devices.

• 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 CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16680836
• MDR Text Key: 312751991
• Report Number: 3005099803-2023-01661
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855927
• UDI-Public: 08714729855927
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/05/2023

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
• Device Operator: Health Professional
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0029939295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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