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 Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tines of the electrode were difficult to deploy.A radiofrequency ablation procedure of the liver was being performed.A leveen coaccess electrode was selected for use to ablate the renal tumor.It was noted there was a bad deployment of the tines on the electrode.Another electrode was used to complete the procedure.There were no patient complications.

• 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: 9186834
• Report Number: 2134265-2019-12392
• Device Sequence Number: 2323656
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: 08714729454939
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140506
• 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
• Report Date (Section B): 10/14/2019

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 Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0023746080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/14/2019
• Patient Sequence Number: 1