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

Model Number	M00562340
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used during a procedure performed on an unknown date.During the procedure, the device did not pass electrical current.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used during a procedure performed on an unknown date.During the procedure, the device did not pass electrical current.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date of july 01, 2022 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: medical device code a090402 captures the reportable event of could not deliver energy.Block h10: (product investigation) one captivator snare was received for analysis.Visual analysis of the device noted that the working length got bent however the active cord noted that it did not have any defective condition.Dimensional evaluation of the returned device found that the 2 in 1 was within of range.Continuity test was also performed, and the device's electrical resistance was within specification, indicating a proper connection the reported event of "device failure to deliver energy" could not be confirmed since no issues were noted with the electrical device testing during continuity test upon return.The product record review confirmed that this is not a new failure type, and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found the working length bent during visual test.No issues were noted with the electrical device testing during continuity test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.

• Brand Name: CAPTIVATOR
• Common Device Name: 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: 15125425
• Report Number: 3005099803-2022-04012
• Device Sequence Number: 5601803
• Product Code: FDI
• UDI-Device Identifier: 08714729747871
• UDI-Public: 08714729747871
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K941750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2024
• Device Model Number: M00562340
• Device Catalogue Number: 6234
• Device Lot Number: 0028021113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown