MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REPROCESSED VIEWFLEX VF04; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	D087031-R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the pvc ablation, the viewflex catheter fractured.The catheter was placed in the left femoral vein via a non-abbott sheath (cook brand 10f sheath).When inserted into the sheath, the catheter fractured.The device was replaced and there were no adverse patient consequences.
Additional Manufacturer Narrative
One reprocessed viewflex vf04 catheter was received for evaluation.The catheter tip was noted to have multiple fractures.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported fracture remains unknown.

• Brand Name: REPROCESSED VIEWFLEX VF04
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND 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 n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21424318
• Report Number: 2182269-2025-00001
• Device Sequence Number: 7913365
• Product Code: OWQ
• UDI-Device Identifier: 05415067041630
• UDI-Public: (01)05415067041630(10)10578758(17)250930
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K231588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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 Expiration Date: 09/30/2025
• Device Model Number: D087031-R
• Device Catalogue Number: D087031-R
• Device Lot Number: 10578758
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female