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

Model Number M00562321

Device Problem Break (1069)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a captivator medium oval stiff snare was received for analysis.Visual inspection of the returned device revealed that the snare loop was detached from the distal cannula, however, the loop was not returned.No other problems were noted.The reported event of "handle break" was not confirmed since the analysis of the device found the handle was in good conditions.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Upon product analysis it was observed that the loop was detached.Evidence of torque was noted on the cannula which shows that the process was done in the unit and that ensures that the components were attached.These types could occur during its manipulation and due to the force applied over the device.Most likely procedural factors as handling of the device, the technique used by the physician during initial use, set-up, power-up, or shortly thereafter could have affected its performance and its intended purpose, leading to the reported event.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.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a captivator medium oval stiff snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, when opening the device, the handle broke.The procedure was completed with a different snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the snare loop was detached.

• 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: 13792490
• MDR Text Key: 288601183
• Report Number: 3005099803-2022-01348
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K131700
• 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: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0025949857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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: 45 YR
• Patient Sex: Male