MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION SPIRAL¿ VARIABLE RADIUS CATHETER 6 F LOOP BI-DIRECTIONAL, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	402804
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, the catheter shaft separated.The device was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.Multiple bends in the shaft and a tear in the spiral loop/shaft transition was noted.The catheter shaft did not meet specifications when deflected in either direction, and the spiral loop no longer deflected in the correct shape according to specifications, due to the aforementioned damage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the tear at the spiral loop transition and bends in the shaft remains unknown.

• Brand Name: REFLEXION SPIRAL¿ VARIABLE RADIUS CATHETER 6 F LOOP BI-DIRECTIONAL, 7F
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14859185
• Report Number: 2182269-2022-00030
• Device Sequence Number: 5074077
• Product Code: DRF
• UDI-Device Identifier: 05414734206204
• UDI-Public: 05414734206204
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062251
• 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,Followup
• Report Date (Section B): 10/27/2022

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: 01/31/2025
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 8339522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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