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	02/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle had difficulty being extended.A radio frequency ablation procedure was being performed on a patient with kidney injury.The leveen coaccess was being used for this procedure.When the needle was deployed after puncture, it was reported that it did not deploy properly.The physician was concerned of non-optimal treatment, so the device was removed.The procedure was completed with a new device.There were no patient complications that were reported.The patient is doing well.
Additional Manufacturer Narrative
Device evaluated by mfr: the electrode and the coaccess cannula were returned for analysis.No visual damages defects were observed on the electrode, handle, cannula.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.
Event or Problem Description
It was reported that the needle had difficulty being extended.A radio frequency ablation procedure was being performed on a patient with kidney injury.The leveen coaccess was being used for this procedure.When the needle was deployed after puncture, it was reported that it did not deploy properly.The physician was concerned of non-optimal treatment, so the device was removed.The procedure was completed with a new device.There were no patient complications that were reported.The patient is doing well.

• 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: 8433178
• Report Number: 2134265-2019-02535
• Device Sequence Number: 1664543
• 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,Followup
• Report Date (Section B): 04/26/2019

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: 11/26/2021
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0022992779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/26/2019
• Patient Sequence Number: 1
• Patient Age: 81 YR