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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that difficulty to extend a needle occurred.During a radiofrequency ablation procedure, a 3.0cm leveen superslim electrode was advanced into the target lesion.However, it was noticed that the needle electrode was not fully deployed and could not be used normally.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr.: the unit was returned with its original pouch batch 24747605.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection confirmed one rf probe was returned for analysis (electrode).The two tines were bent at the distal section.Functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.
Event or Problem Description
It was reported that difficulty to extend a needle occurred.During a radiofrequency ablation procedure, a 3.0cm leveen superslim electrode was advanced into the target lesion.However, it was noticed that the needle electrode was not fully deployed and could not be used normally.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.

• 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: 10960747
• Report Number: 2134265-2020-16342
• Device Sequence Number: 16941301
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: 08714729441717
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 11/10/2022
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0024747605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 75