MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	402807
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 2182269-2025-00004.During a paroxysmal supraventricular tachycardia procedure, the catheters could not be straightened causing a procedure delay.When bending the catheter, it could not be straightened.The catheter was replaced and the same issue occurred.A third catheter was used to complete the procedure with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.One 4mm tip, medium sweep, safire ablation catheter was received for evaluation.Visual inspection revealed bends in the catheter shaft in multiple locations.The catheter deflected in both directions when actuating the steering mechanism; however, did not deflect in the correct shape in either direction and no longer met specifications, due to the bends in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bends and subsequent delay remains unknown.

• Brand Name: SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21641739
• Report Number: 2182269-2025-00005
• Device Sequence Number: 20739355
• Product Code: LPB
• UDI-Device Identifier: 05414734205986
• UDI-Public: (01)05414734205986(10)10325335(17)270430
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P960016
• 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): 04/16/2025

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 Model Number: 402807
• Device Catalogue Number: 402807
• Device Lot Number: 10325335
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SAFIRE¿ BI-DIRECTIONAL ABLATION CATH
• Patient Age: 46 YR
• Patient Sex: Female