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	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was not reported; the aware date was used as an estimate.
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 kidney cancer.The leveen co-access was being used for this procedure.When the needle was in position, it was attempted to be unfolded.It was reported that the device didn't open correctly, and it stayed in a narrow, twisted, configuration.This device was replaced with another one, but the same issue occurred with the unfolding of the device.The procedure was completed with another of the same device.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: 10676693
• Report Number: 2134265-2020-13895
• Device Sequence Number: 14110097
• Product Code: GEI
• UDI-Device Identifier: 08714729295617
• UDI-Public: 08714729295617
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K140505
• 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): 10/14/2020

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: 07/13/2023
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0025705139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/14/2020
• Patient Sequence Number: 1