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

Model Number	36700
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle had high impedance and early roll-off.A radio frequency ablation procedure was being performed on a tumor for a patient.The leveen coaccess electrode was being used for this procedure.The needle was positioned in the lesion.At the moment of heating the lesion, the impedance was immediately very high and there was very early roll-off.The needle was replaced with one from a different lot, but the same problem occurred.There were no patient complications that were reported.
Event or Problem Description
It was reported that the needle had high impedance and early roll-off.A radio frequency ablation procedure was being performed on a tumor for a patient.The leveen coaccess electrode was being used for this procedure.The needle was positioned in the lesion.At the moment of heating the lesion, the impedance was immediately very high and there was very early roll-off.The needle was replaced with one from a different lot, but the same problem occurred.There were no patient complications that were reported.It was further reported that the roll off was reached with the second needle and no third needle was needed.The patient was discharged from the hospital and is doing well.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of one coaccess electrode system was returned for analysis (cable and electrode).No visual damages/defects were observed on the electrode/cable.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.
Event or Problem Description
It was reported that the needle had high impedance and early roll-off.A radio frequency ablation procedure was being performed on a tumor for a patient.The leveen coaccess electrode was being used for this procedure.The needle was positioned in the lesion.At the moment of heating the lesion, the impedance was immediately very high and there was very early roll-off.The needle was replaced with one from a different lot, but the same problem occurred.There were no patient complications that were reported.It was further reported that the roll off was reached with the second needle and no third needle was needed.The patient was discharged from the hospital and is doing well.

• 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: 8574158
• Report Number: 2134265-2019-04643
• Device Sequence Number: 1992629
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2019

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: 02/04/2022
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0023296882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 06/28/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/29/2019; 07/05/2019
• Patient Sequence Number: 1
• Patient Age: 66 YR