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	01/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle had difficulty being deployed.A radio frequency ablation procedure was being performed on a right upper pole renal tumor lesion of tissue nature of 20 mm (long axis).The leveen coaccess was being used for this procedure.When the needle was deployed, it was reported that it was unable to be deployed entirely.Another of the same device was then used and the procedure was completed.There were no patient complications that were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: one rf probe was returned for analysis (electrode).The two tines were bent at distal section.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.
Event or Problem Description
It was reported that the needle had difficulty being deployed.A radio frequency ablation procedure was being performed on a right upper pole renal tumor lesion of tissue nature of 20 mm (long axis).The leveen coaccess was being used for this procedure.When the needle was deployed, it was reported that it was unable to be deployed entirely.Another of the same device was then used and the procedure was completed.There were no patient complications that were reported.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11297784
• Report Number: 2134265-2021-01422
• Device Sequence Number: 17392741
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: 08714729454922
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 10/13/2023
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0026177089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR