MAUDE Adverse Event Report: ST. JUDE MEDICAL HYDROSTEER GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	405063
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the wire was in the mesenteric artery and the physician was attempting to move a non-abbott device (6fr merit sheath with a terumo glidecath 4fr) over the wire when it was noted that the device was difficult to remove, resistance was felt.The wire was not through anything metal.It was then observed that the hydrophilic coating was not at the tip of the wire, it appeared to be separating from the tip.The device was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One hydrosteer guidewire was received for evaluation.The core wire was noted to be protruding from the tip of the black hydrophilic coating of the guidewire.Hydrosteer instructions for use states ¿if resistance if felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the guidewire and device as a unit to prevent possible damage and/or complications¿.The cause of the reported event is consistent with not following the instructions for use.

• Brand Name: HYDROSTEER GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19825878
• Report Number: 3005334138-2024-00317
• Device Sequence Number: 8684685
• Product Code: DQX
• UDI-Device Identifier: 05414734055017
• UDI-Public: (01)05414734055017(10)9944212(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000011
• 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): 12/05/2024

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 Model Number: 405063
• Device Catalogue Number: 405063
• Device Lot Number: 9944212
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White