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

Model Number	36705
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bent needle occurred.The target lesion was located in the liver.A 2.0x17x15 leveen superslim was selected for use.During the procedure, the impedance rise of the radio frequency (rf) machine was completed and an abnormal needle was found after the needle was pulled out of the patient.The procedure was completed with another of the same device.There were no patient complications and the patient's status is stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the returned device matches with upn provided by the customer.One rf probe was returned for analysis (electrode).No visual damage or defects were observed on the electrode.The tines were kinked at the distal section.The device shows residue, evidence of use.The tines were extended and retracted without resistance during a functional evaluation.
Event or Problem Description
It was reported that a bent needle occurred.The target lesion was located in the liver.A 2.0x17x15 leveen superslim was selected for use.During the procedure, the impedance rise of the radio frequency (rf) machine was completed and an abnormal needle was found after the needle was pulled out of the patient.The procedure was completed with another of the same device.There were no patient complications and the patient's status is stable.

• Brand Name: LEVEEN SUPERSLIM
• 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: 13969397
• Report Number: 2134265-2022-03608
• Device Sequence Number: 14644480
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113090
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 08/11/2024
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0027825706
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 78 KG