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

Model Number M00562451

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2022.After the procedure, the tech went to disconnect the snare from the cautery cord and the brass prong inside the cautery port on the snare came out.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Block h6: problem code (b)(6)captures the reportable event of cautery pin detached.Block h10: investigation results a captivator small hexagonal stiff snare was received for analysis.Visual and microscope analysis of the returned device revealed that the 2 in 1 pin was detached from the handle.During the product analysis the handle cord was separated from the active cord insert in order to evaluate the handle cannula.The handle cannula had torque mark which was evidence of the correct process (the 2 in 1 was correctly positioned in the active cord insert).Media inspection of the photo provided by the customer revealed that the 2 in 1 was separated from the handle.No other problems were noted.The reported complaint of cautery pin detachment of device or device component was confirmed since the device was returned with the 2 in 1 pin separated from the handle.Evidence of torque mark was noted on the handle cannula which shows that the process was done in the unit and that ensures that the component was attached correctly.These types of problems can occur during device manipulation.Most likely procedural factors such as handling of the device, the technique used by the physician during removal of the active cord thereafter could have affected its performance, leading to the reported event.Finally, based in the external form provided by the manufacturing team the product builders have to confirm the 2 in 1 pin condition several times.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.This is defined as the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6)2022.After the procedure, the tech went to disconnect the snare from the cautery cord and the brass prong inside the cautery port on the snare came out.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

• 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: 15438331
• MDR Text Key: 301980555
• Report Number: 3005099803-2022-05205
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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
• Device Operator: Health Professional
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0029390914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• 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: 73 YR
• Patient Sex: Male