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

Model Number M00561241

Device Problems Retraction Problem (1536); Failure to Cut (2587)

Patient Problem Burn(s) (1757)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Investigation analysis: a captivator ii-20mm round stiff snare was received for analysis.Visual evaluation revealed that the device did not have any defective condition.Functional evaluation of the returned device found that the device was tested in the 10-inch loop fixture and it was able to extend completely and retract without issues.Continuity test was also performed and the device passed the continuity test since the device's electrical resistance was 6.9 ohms, indicating a proper connection (the electrical resistance shall be less than 20 ohms per non-rotatable snares electrical resistance).A risk review of the captivator - snares was completed using the snare family global design fmea, bsc, bv and confirmed that the events of "snare- loop-failure to cut", "retraction problem" and "burn(s) " were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications, however there is no control how the devices are handled/manipulated in the field.Based on the information available and the analysis performed, the most probable root cause for this problem is no problem detected since the device complaint or problem cannot be confirmed.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a captivator ii-20mm round stiff snare was used during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the wire could not get into the sheath and the device was unable to cut the target polyp.When the snare loop was slightly out, it was able to strangulate the polyp, so it was burnt.Reportedly, the snare was securely attached to the active cord and no visible issue was noted with the cautery pin.The procedure was completed with this device.The device caused a burn to the patient.The patient's condition following the procedure was reported to be no problem.

• 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: 10661761
• MDR Text Key: 225729647
• Report Number: 3005099803-2020-04522
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: M00561241
• Device Catalogue Number: 6124
• Device Lot Number: 0025100885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2020
• 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