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

Model Number	M001262220
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that they were unable to open the tines.A radiofrequency ablation procedure was being performed in the patient's liver.A 3.0/15/15 leveen¿ coaccess¿ was selected and positioned in the patient.However, they were unable to deploy the tine.The device was removed from the patient.The procedure was completed with another of the same device.No patient complications were reported and the patients status is fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: examination of the returned complaint device revealed that the electrode array was fully retracted.The device returned has residues which is evidence of use/handling.The device is slightly bent.A functional evaluation extended and retracted the tines, some resistance was found due to residues in the tines and cannula bent.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 operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that they were unable to open the tines.A radiofrequency ablation procedure was being performed in the patient's liver.A 3.0/15/15 leveen¿ coaccess¿ was selected and positioned in the patient.However, they were unable to deploy the tine.The device was removed from the patient.The procedure was completed with another of the same device.No patient complications were reported and the patients status is fine.

• Brand Name: LEVEEN¿ COACCESS¿
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7078567
• Report Number: 2134265-2017-11890
• Device Sequence Number: 11130209
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: 08714729454922
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K012315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2017

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: 02/28/2019
• Device Model Number: M001262220
• Device Catalogue Number: 26-222
• Device Lot Number: 0018896990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR