MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN COACCESS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	36700
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event was not reported but estimated using the aware date.
Event or Problem Description
It was reported that the array was difficult to deploy.A 3.0cm x 15cm leveen coaccess needle electrode system was selected for use in a radiofrequency ablation procedure.Before starting the procedure, the needle was deployed to check its operation, but an unusual resistance or stiffness was encountered.Therefore, a different stock was used.There were no patient complications reported.
Additional Manufacturer Narrative
B3: date of event was not reported but estimated using the aware date.Device eval by manufacturer: the electrode device was returned.During product analysis, no damages were observed at the handle and needles/tines.It was possible to observe that the device was bent at the cannula.The handle was extended and retracted, and the needle/tines could be activated without any problems.
Event or Problem Description
It was reported that the array was difficult to deploy.A 3.0cm x 15cm leveen coaccess needle electrode system was selected for use in a radiofrequency ablation procedure.Before starting the procedure, the needle was deployed to check its operation, but an unusual resistance or stiffness was encountered.Therefore, a different stock was used.There were no patient complications reported.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19263817
• Report Number: 2124215-2024-27010
• Device Sequence Number: 19504453
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: 08714729454922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140504
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

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 Model Number: 36700
• Device Catalogue Number: 36700
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown