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

Model Number	36705
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle had difficulty being extended.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen superslim was being used for this procedure.When the needle was in position it was attempted to be unfolded.It was reported that the device handle was too tight to be used and it could not be completely unfolded.The procedure was completed with another of the same device.There were no patient complications that were reported.
Event or Problem Description
It was reported that the needle had difficulty being extended.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen superslim was being used for this procedure.When the needle was in position it was attempted to be unfolded.It was reported that the device handle was too tight to be used and it could not be completely unfolded.The procedure was completed with another of the same device.There were no patient complications that were reported.
Additional Manufacturer Narrative
Visual inspection.One rf probes was returned for analysis.The electrode and the coaccess cannula introducer were returned for analysis.No visual damages defects were observed on the electrode, handle, functional inspection.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.

• Brand Name: LEVEEN SUPERSLIM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10176417
• Report Number: 2134265-2020-07813
• Device Sequence Number: 19564329
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113090
• 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
• Report Date (Section B): 07/08/2020

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: 07/31/2020
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0020954413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/08/2020
• Patient Sequence Number: 1
• Patient Age: 33 YR