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 Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the electrode was bent.A radiofrequency ablation of primary liver cancer was performed.The size of the tumor was 4.0cm, so the physician used a 3.0/17/15 leveen superslim needle electrode to perform ablation.For the first and the second time, it was successfully punctured and ablated.But when the physician changed the puncture path and adjusted the needle, the tip of the needle was found to be curved.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the needle electrode was returned for analysis.The tines were extended when received.The electrode was bent at distal section, also the electrode is damaged (cracked) approximately at 4cm from the needle tip, there was evidence of bending near the broken area.The tines and core wire are also bent.The handle was actuated, however the tines did not retract due to the core wire that was found detached.
Event or Problem Description
It was reported the electrode was bent.A radiofrequency ablation of primary liver cancer was performed.The size of the tumor was 4.0cm, so the physician used a 3.0/17/15 leveen superslim needle electrode to perform ablation.For the first and the second time, it was successfully punctured and ablated.But when the physician changed the puncture path and adjusted the needle, the tip of the needle was found to be curved.The procedure was completed with another of same device.There were no patient complications reported.

• 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: 9432187
• Report Number: 2134265-2019-14868
• Device Sequence Number: 2237923
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 06/09/2022
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0023927425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 62