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

Model Number	36719
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle had difficulty being deployed.A radio frequency ablation procedure was being performed on a hepatic carcinoma tumor.The leveen standard was being used for this procedure.After the first ablation with the device, the physician retracted the tines in order to advance it a bit in the tumor.However, he was then not able to extend the tines again.The procedure was aborted.There were no patient complications.The patient condition was good.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8751526
• Report Number: 2134265-2019-07321
• Device Sequence Number: 13962627
• Product Code: GEI
• UDI-Device Identifier: 08714729300618
• UDI-Public: 08714729300618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140496
• 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): 07/01/2019

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: 03/03/2022
• Device Model Number: 36719
• Device Catalogue Number: 36719
• Device Lot Number: 0023432068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 07/01/2019
• Patient Sequence Number: 1