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 Codes	Use of Device Problem (1670); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an afib procedure, when the catheter was plugged in for mapping in the left atrium, an error message popped up on the dws that said ¿possible catheter or port issue error.¿ the ports were switched and the precision link was power cycled, but the issue persisted.The catheter cable was also replaced with no change in error status.The device was replaced and the procedure was completed with no adverse consequences to the patient.It was noted that the device used in the patient was expired.
Additional Manufacturer Narrative
One 15mm loop, bi-directional, curve d-f, sensor enabled, advisor fl circular mapping catheter was received for evaluation. the sensor met specifications for 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 reported error message remains unknown.

• 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; 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: 12664784
• Report Number: 3008452825-2021-00483
• Device Sequence Number: 19462868
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 07/31/2021
• Device Model Number: D-AVSE-DF10-F15
• Device Catalogue Number: D-AVSE-DF10-F15
• Device Lot Number: 7396730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 93