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-F15
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a pulmonary vein isolation ablation procedure, resistance was noted when inserting the catheter and the device could not be advanced past the hemostasis valve of the sheath.Upon removal from the patient, the distal electrode was separated from the catheter.The catheter was replaced and the procedure was completed with no adverse consequences onto the patient.
Additional Manufacturer Narrative
One 15 mm loop, bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation.The distal electrode was noted to be dislodged from the grey shaft material, exposing the base of the distal electrode assembly.No other visual anomalies were noted.The cause of the partially separated tip electrode and the reported insertion difficulty is consistent with not using the tip straightener to straighten the loop during insertion of the catheter into the introducer sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• 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: 7604810
• Report Number: 3005334138-2018-00159
• Device Sequence Number: 18902944
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 01/31/2019

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: 07/31/2019
• Device Model Number: D-AVSE-DF10-F15
• Device Lot Number: 6317177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1