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

Model Number	M00562321
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(initial reporter address) (b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium oval stiff snare was to used remove intestinal polyps in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, the trap was connected to the electrode, but no reaction was observed when cutting with electricity.The procedure was completed with another of the same device.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 stable.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium oval stiff snare was to used remove intestinal polyps in the intestinal tract during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2022.During the procedure and inside the patient, the trap was connected to the electrode, but no reaction was observed when cutting with electricity.The procedure was completed with another of the same device.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 stable.
Additional Manufacturer Narrative
Block e1: (initial reporter address): (b)(6).Block h6: medical device code a090402 captures the reportable event of unable to deliver energy.Block h10: (product investigation): one captivator snare was received for analysis.Visual analysis of the device did not find any problems.The active cord did not find any problems.Dimensional testing of the active cord was performed, and it is within specifications.Electrical testing was performed, and the device's electrical resistance was within specification.The reported event of device unable to deliver energy could not be confirmed.Device analysis found no problems with the device during visual, dimensional and electrical tests.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.This code was selected since the reported event could not be confirmed.

• 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: 15393287
• Report Number: 3005099803-2022-05087
• Device Sequence Number: 20359056
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131700
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: 01/14/2025
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0028669861
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG