MAUDE Adverse Event Report: ST. JUDE MEDICAL REFLEXION¿ HD HIGH DENSITY CATHETER, 5 F LOOP BI-DIRECTIONAL, 99 CM LENGTH, SYMM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	D402864
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report is to advise of a short circuit found during analysis.
Additional Manufacturer Narrative
One duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.Electrode 6 displayed acceptable resistance values; however, a short circuit was detected between electrode 5 and conductor wires 1, 13 and 18.Dissection revealed no apparent wire damage or visible root cause for the short circuit detected.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the short circuit remains unknown.

• Brand Name: REFLEXION¿ HD HIGH DENSITY CATHETER, 5 F LOOP BI-DIRECTIONAL, 99 CM LENGTH, SYMM
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15794898
• Report Number: 2182269-2022-00058
• Device Sequence Number: 4675009
• Product Code: DRF
• UDI-Device Identifier: 05414734217262
• UDI-Public: 05414734217262
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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: 02/28/2025
• Device Model Number: D402864
• Device Catalogue Number: D402864
• Device Lot Number: 8381894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown