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	10/14/2020
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 tumor for a patient with cancer.The leveen coaccess was being used for this procedure.When the needle was deployed after puncture, it was reported that it was unable to be deployed properly.Another of the same device was then unpacked and the procedure was completed.There were no patient complications that were reported.

• 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: 10759177
• Report Number: 2134265-2020-14919
• Device Sequence Number: 11609426
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: 08714729454922
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140504
• 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): 10/29/2020

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: 12/08/2022
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0024897426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1