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 Patient Involvement (2645)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was stuck.A 4.0/15/15 leveen coaccess electrode was selected for use in a radiofrequency ablation procedure.Prior to use a functional check was performed outside the patient.During the check, the electrodes did not come out properly; they were twisted over each other.The device was not used.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: one rf probe was received with its tines in closed/retracted position.No visual defects were noted, the returned product looks under good conditions without evidence of damages or anomalies; the prongs are not twisted, deformed or damaged.The handle was actuated moving it forward and backward and the tines of the returned device could be extended and retracted properly without problems or resistance.
Event or Problem Description
It was reported that the needle was stuck.A 4.0/15/15 leveen coaccess electrode was selected for use in a radiofrequency ablation procedure.Prior to use a functional check was performed outside the patient.During the check, the electrodes did not come out properly; they were twisted over each other.The device was not used.The procedure was completed with another of the same device.No patient complications 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: 8340975
• Report Number: 2134265-2019-00757
• Device Sequence Number: 13504376
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: 08714729454939
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 02/11/2021
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 21731938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/18/2019
• Patient Sequence Number: 1