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

Model Number	36705
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle had difficulty being extended.A radiofrequency ablation procedure was being performed.The 3.0/17/15 leveen superslim was selected for use.During the procedure, the needle did not deploy or extend properly.They replaced the needle and the procedure was completed.There were no patient complications.
Event or Problem Description
It was reported that the needle had difficulty being extended.A radiofrequency ablation procedure was being performed.The 3.0/17/15 leveen superslim was selected for use.During the procedure, the needle did not deploy or extend properly.They replaced the needle and the procedure was completed.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the electrode was returned for analysis.No visual damages defects were observed on the electrode, handle, cannula and connector.The device was free of obvious kinks and bends.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.

• Brand Name: LEVEEN SUPERSLIM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9403846
• Report Number: 2134265-2019-14831
• Device Sequence Number: 11304485
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: 08714729441717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 06/17/2022
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0023972259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1