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	06/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tines of the electrode were unable to extend.A radiofrequency ablation procedure of the liver was being performed.A leveen coaccess electrode was attempted to be used, but the tines of the electrode would not extend.The physician attempted the use of strong force, but was still unable to extend the tines.Another electrode was used to successfully ablate the liver.There were no patient complications reported.The patient was stable.

• 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: 8821712
• Report Number: 2134265-2019-08279
• Device Sequence Number: 10848538
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: 08714729454939
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/24/2019

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: 03/04/2022
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0023439047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1
• Patient Age: 61 YR