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

Model Number M00561231

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a captivator ii-15mm round stiff snare was received for analysis.Visual inspection of the returned device revealed that the flare catheter was detached at the handle section and the loop was received exposed at the catheter distal section.Functional evaluation of the returned device revealed that when the device was manually actuated, the snare loop was unable to retract inside the catheter.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.The device received has the snare loop exposed and the flare catheter was detached at the distal section.Additionally, the device was manually actuated and the snare loop was unable to retract inside the catheter due to the detached condition.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.The investigation has not identified a potential process or design related issue for the batch number, further review at batch level is not required at this time.Emerging trends are captured as part of the post market signal evaluation and escalation process.A risk review of the captivator - snares was completed using the snare family global design workbook and confirmed that the event of "snare- loop-failure to cut" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.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 ii-15mm round stiff snare was used during a endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, when trying to cut/remove the target polyp, it could not strangulate or cut the polyp even after grabbing the handle.Reportedly, the instructions during preparation were followed.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10771110
• MDR Text Key: 214138461
• Report Number: 3005099803-2020-05032
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: 08714729855910
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2023
• Device Model Number: M00561231
• Device Catalogue Number: 6123
• Device Lot Number: 0025556852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2020
• 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