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

Model Number M00561222

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Investigation results: a captivator snare was received for analysis.Visual inspection of the returned device revealed that the handle cannula was in good condition, however, the snare loop was found broken and blackened/burned.Additionally, the sheath has evidence of residues at the distal section.Per resistance test, the electrical resistance shall be less than 20 ohms.Based on that, this device passed continuity test since device's electrical resistance was 10.2 ohms, indicating a proper connection.No other issues were noted.Based on the event description, the problem was noticed during procedure, it was confirmed that the device has the snare loop broken and evidence of blackened/burn was identified.This failure mode could be caused due to an excessive application of power during the process, which caused an overheating resulting to the burn and the break of the snare loop.Additionally, during the manufacturing process, the units were inspected as per procedure to avoid anomalies and verify the correct assembly of the loop which confirms that the device was sent in good conditions to the customer.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure.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-10mm round stiff snare was used during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, cautery was used on the snare and a small flame was seen coming from the device and then the snare loop broke.The procedure was completed using a biopsy forceps.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 fine.

• 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: 10843244
• MDR Text Key: 216375311
• Report Number: 3005099803-2020-05237
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729861300
• UDI-Public: 08714729861300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: M00561222
• Device Catalogue Number: 50296
• Device Lot Number: 0025793007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1