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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty to extend a needle occurred.A radiofrequency ablation procedure was performed on a lesion located in the liver.A 4.0 leveen coaccess electrode was advanced to the lesion, but the device did not fully deploy.The device was removed and the procedure was completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
Event or Problem Description
It was reported that difficulty to extend a needle occurred.A radiofrequency ablation procedure was performed on a lesion located in the liver.A 4.0 leveen coaccess electrode was advanced to the lesion, but the device did not fully deploy.The device was removed and the procedure was completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit was returned with its original pouch batch 23673909.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.A visual inspection confirmed one rf probe was returned for analysis (electrode).No visual damages or defects were observed on the electrode.The electrode connector and cable connector did not have any visual defect.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.

• 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: 11055486
• Report Number: 2134265-2020-18297
• Device Sequence Number: 2974544
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: 08714729454939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140506
• 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: 04/21/2022
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0023673909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 12/22/2020
• 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: 57 YR
• Patient Weight: 55