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

Model Number	M00562341
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 to remove a large pedunculated polyp with stalk during an unknown procedure performed on (b)(6) 2022.It was reported that during the procedure, the snare did not cut or cauterize the target polyp.They could hear the pedal was working but electrical energy wasn't working at all.The procedure was completed with a sensation snare.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the reported event date is january 22, 2022; the event date listed in mw5108468 is february 14, 2022.Block d4: the reported lot number is 0028420760; the lot number listed in mw5108468 is 28201832.Block g2: report source (user facility) maude report mw5108468 received on april 14, 2022.Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Problem code a090402 captures the reportable event of snare unable to deliver energy.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: 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.Block h11: block b5 and g2 has been updated based on the additional information received on april 14, 2022.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during an unknown procedure performed on (b)(6) 2022.It was reported that during the procedure, the snare did not cut or cauterize the target polyp.They could hear the pedal was working but electrical energy wasn't working at all.The procedure was completed with a sensation snare.There were no patient complications reported as a result of this event.Additional information received on april 14, 2022.Erbe unit was checked in january 2022.

• 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: 14031076
• Report Number: 3005099803-2022-01788
• Device Sequence Number: 19966189
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: 11/21/2024
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0028420760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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 Sex: Unknown