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

Model Number	M001262260
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported there was difficulty deploying the array.A 2.0/17/15 leveen¿ superslim¿ was selected for a radiofrequency ablation procedure.When attempting to deploy the device while outside of the patient, the handle portion was difficult and it was unable to be deployed smoothly.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer, evaluation summary attached, method codes, result codes, conclusion codes: updated.Device evaluated by manufacturer: examination of the returned complaint device revealed that the electrode array was fully retracted.No visible damages were found to cannula or handle.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
It was reported there was difficulty deploying the array.A 2.0/17/15 leveen¿ superslim¿ was selected for a radiofrequency ablation procedure.When attempting to deploy the device while outside of the patient, the handle portion was difficult and it was unable to be deployed smoothly.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: LEVEEN¿ SUPERSLIM¿
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7285013
• Report Number: 2134265-2018-01320
• Device Sequence Number: 16473063
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• PMA/510(K) Number: K012315
• 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,Followup
• Report Date (Section B): 01/31/2018

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: 07/31/2020
• Device Model Number: M001262260
• Device Catalogue Number: 26-226
• Device Lot Number: 0020954413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1