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

Model Number	36700
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was insufficient roll-off.A leveen coaccess was selected for use to treat a case of cancer in the liver.When roll-off was attempted, it was noted that it took longer than usual.By increasing the cauterization range in stages, roll-off was possible at about 180 w when the range was narrow.However, when the range was increased, roll-off did not occur, even at 200 w.The procedure was completed using this device and there were no reported patient injuries as a result of the malfunction.
Event or Problem Description
It was reported that there was insufficient roll-off.A leveen coaccess was selected for use to treat a case of cancer in the liver.When roll-off was attempted, it was noted that it took longer than usual.By increasing the cauterization range in stages, roll-off was possible at about 180 w when the range was narrow.However, when the range was increased, roll-off did not occur, even at 200 w.The procedure was completed using this device and there were no reported patient injuries as a result of the malfunction.
Additional Manufacturer Narrative
Device analysis: the complaint device was returned for analysis.Visual examination revealed no damage to the device.The handle was extended and retracted, and the needle could be activated without any issue.Continuity and functional tests were carried out and both passed.Laboratory analysis was unable to confirm the reported observation.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18676171
• Report Number: 2124215-2024-07221
• Device Sequence Number: 12310660
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: 08714729454939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: 06/26/2026
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0031902895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown