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	02/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was insufficient roll-off.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen coaccess was being used for this procedure.The device was positioned in the patient and the ablation was performed.The impedance value increased, but the device would not roll off easily.The procedure was continued using the same device.The procedure was completed successfully and there were no patient complications that occurred.
Additional Manufacturer Narrative
Device evaluated by mfr: one coaccess electrode system was returned for analysis (coaccess electrode, introducer cannula and cable).From the coaccess introducer set, only the introducer cannula was received, the stylet was not returned.Additionally some pads were returned.No visual damages defects were observed on the electrode, introducer cannula and cable.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.Residues were found in the tines.Electrical inspection was within specification.
Event or Problem Description
It was reported that there was insufficient roll-off.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen coaccess was being used for this procedure.The device was positioned in the patient and the ablation was performed.The impedance value increased, but the device would not roll off easily.The procedure was continued using the same device.The procedure was completed successfully and there were no patient complications that occurred.

• 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: 9808131
• Report Number: 2134265-2020-02219
• Device Sequence Number: 10923382
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 04/30/2020
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0020493539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1