MAUDE Adverse Event Report: ST. JUDE MEDICAL 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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, the catheter broke during insertion through the sheath; internal wires were exposed.The catheter was exchanged and the procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
Additional information revealed the initial mdr for this event was reported under the incorrect mfr report # and manufacturing site.Corrected manufacturing site information has been provided in g1.The correct mfr number is 2182269.
Additional Manufacturer Narrative
One duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.Bends in multiple locations throughout the catheter shaft and spiral loop as well as a tear in the spiral loop/shaft transition were noted.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 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15508617
• Report Number: 3005334138-2022-00536
• Device Sequence Number: 5181803
• 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,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: 09/16/2022
• Supplement Date Received by Manufacturer: 10/26/2022; 10/26/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/27/2022; 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
• Patient Sequence Number: 1
• Patient Sex: Unknown