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

Model Number	36717
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tines were difficult to extend.A radiofrequency ablation (rfa) procedure was being performed.A leveen standard 3.0/15/15 electrode was selected for use.During preparation, the user noticed the deployment of the tines were stiff.The device was not used.Another leveen standard electrode was used and the procedure was completed successfully.There were no patient complications.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8949232
• Report Number: 2134265-2019-10409
• Device Sequence Number: 2510382
• Product Code: GEI
• UDI-Device Identifier: 08714729300632
• UDI-Public: 08714729300632
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140498
• 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
• Report Date (Section B): 08/30/2019

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: 02/12/2022
• Device Model Number: 36717
• Device Catalogue Number: 36717
• Device Lot Number: 0023343240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/30/2019
• Patient Sequence Number: 1