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

Model Number	D-AVSE-D10-F15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation.The tip electrode was partially separated from the loop shaft and conductor wire 1 was fractured proximal to the electrode.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.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 advisor fl circular mapping catheter instructions for use (ifu) precautions, ¿always straighten the catheter before insertion or withdrawal".The cause of the open circuit is consistent with the loop damage.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a separated electrode on the catheter.

• 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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8296927
• Report Number: 3008452825-2019-00036
• Device Sequence Number: 19319379
• Product Code: DRF
• UDI-Device Identifier: 05415067024800
• UDI-Public: 05415067024800
• 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
• Report Date (Section B): 02/01/2019

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-D10-F15
• Device Lot Number: 6333558
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1