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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2020
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 pancreas.A 3.0 leveen coaccess electrode was unpacked, the patient was punctured, and the device was advanced to the target lesion, but the device failed to deploy.After the needle ablation, the needle was observed to be deformed.The procedure was completed with another of the same device.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.

• 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: 11055415
• Report Number: 2134265-2020-18296
• Device Sequence Number: 14196776
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 11/26/2021
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0022992779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 76