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	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrial fibrillation procedure, it was noted that the distal end of the catheter fractured upon insertion into the left femoral vein via a 10f long sheath.The catheter was replaced, and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One viewflex eco catheter was received for evaluation.The reported fracture in the catheter shaft was confirmed.The catheter tip was noted to be bent and fractured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Abbott is continuing to monitor this issue.
Event or Problem Description
This report includes updated device information.

• 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: 20435057
• Report Number: 2182269-2024-00035
• Device Sequence Number: 7589778
• Product Code: OWQ
• UDI-Device Identifier: 05415067041630
• UDI-Public: (01)05415067041630(10)10432230(17)250630
• 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): 10/22/2024

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: 06/30/2025
• Device Model Number: D087031-R
• Device Catalogue Number: D087031-R
• Device Lot Number: 10432230
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/12/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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