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

Model Number M00561221

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 Description

It was reported to boston scientific corporation that a captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6) 2021.During the procedure, it was reported that the pin for connecting the a cord has come off or disconnected and the a cord was unable to connect.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a captivator ii round stiff snare was used during a polypectomy procedure performed on (b)(6) 2021.During the procedure, it was reported that the pin for connecting the a cord has come off or disconnected and the a cord was unable to connect.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: (b)(6) block h6: problem code a0501 captures the reportable event of cautery pin detached.Block h10: (product investigation) one captivator snare was received for analysis.The device was visually inspected and it was noted that the cautery pin was broken (detached).The reported event of cautery pin detached was confirmed.During product analysis it was found that the cautery pin was broken (detached).Based on the analysis of the returned device and the information available, the most probable cause for the reported complaint is design inadequate for purpose since there were problems traced to design/design features of the device that do not support or interfere with the intended purpose of the device.An investigation to address this issue is in progress.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: CAPTIVATOR II
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11723789
• MDR Text Key: 247244385
• Report Number: 3005099803-2021-01857
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855903
• UDI-Public: 08714729855903
• Combination Product (y/n): N
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0026360926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1