MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D-AVSE-DF10-F20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sensor enabled, advisor fl circular mapping catheter was received for evaluation.During testing electrode 1 read as an open circuit.Following the dissection of the advisor fl catheter it was determined that the open circuit was caused by a broken tip electrode wire just proximal to the tip electrode.Shaft material was removed in-between the tip and ring electrode 1 and a blood like substance was witnessed under the shaft material due to a void from the shaft material not being flush with the tip electrode.The tip electrode wire was witnessed free floating under the shaft material where evidence of the broken wire was seen within the solder of the tip.Electrode 2 met specifications of acceptable resistance values with no open or short circuits detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the fractured wire remains unknown.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a gap between the shaft material and the tip electrode.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8063671
• Report Number: 3005334138-2018-00428
• Device Sequence Number: 1953099
• Product Code: DRF
• UDI-Device Identifier: 05415067025968
• UDI-Public: 05415067025968
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160335
• 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): 11/13/2018

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: 03/31/2019
• Device Model Number: D-AVSE-DF10-F20
• Device Lot Number: 6157215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1