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

Model Number	36700
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a puncture burn occurred.The patient was undergoing a radiofrequency ablation procedure in their liver.A leveen coaccess probe was used with a rf 3000 generator.The leveen coaccess probe was positioned in the tumor site.It was observed that the array of the device did not appear to be heating up, only the cannula of the device was.The patient's skin became burned.The probe was removed and exchanged for another of the same.The second leveen coaccess probe was positioned and the same issue occurred again.There were no further patient complications.The procedure was completed with a different device.
Additional Manufacturer Narrative
B2 outcomes attrib to adv event, b5 describe event or problem & h6 impact codes: updated.
Event or Problem Description
It was reported a puncture burn occurred.The patient was undergoing a radiofrequency ablation procedure in their liver.A leveen coaccess probe was used with a rf 3000 generator.The leveen coaccess probe was positioned in the tumor site.It was observed that the array of the device did not appear to be heating up, only the cannula of the device was.The patient's skin became burned.The probe was removed and exchanged for another of the same.The second leveen coaccess probe was positioned and the same issue occurred again.There were no further patient complications.The procedure was completed with a different device.It was further reported the insulation of the device remained intact upon removal from the patient.The burn was third degree and the physician cut the burn site to treat it.The patient was stable.It has since been reported the wound is healed.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned device matched the upn provided by the customer.The device was returned with its original pouch.Visual inspection noted one electrode and cable were returned for analysis.No visual damages or defects were observed on the electrode, needle and cable.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.The device met specifications.
Event or Problem Description
It was reported a puncture burn occurred.The patient was undergoing a radiofrequency ablation procedure in their liver.A leveen coaccess probe was used with a rf 3000 generator.The leveen coaccess probe was positioned in the tumor site.It was observed that the array of the device did not appear to be heating up, only the cannula of the device was.The patient's skin became burned.The probe was removed and exchanged for another of the same.The second leveen coaccess probe was positioned and the same issue occurred again.There were no further patient complications.The procedure was completed with a different device.It was further reported the insulation of the device remained intact upon removal from the patient.The burn was third degree and the physician cut the burn site to treat it.The patient was stable.It has since been reported the wound is healed.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13023414
• Report Number: 2134265-2021-15944
• Device Sequence Number: 11954440
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: 08714729454922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0027063288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 12/30/2021; 02/21/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/24/2022; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 61 KG