MAUDE Adverse Event Report: PHILIPS IMAGE GUIDED THERAPY CORPORATION QUICK-CROSS; CATHETER, PERCUTANEOUS

Model Number	518-036-B
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of peripheral arterial disease.Currently, she has gangrene of left lower extremity.Procedure: interventional radiology arteriogram, left lower extremity angiogram with stent placement to left common iliac.During the procedure, the metal markers for catheter became dislodged and moved.Surgeon was able to manipulate markers without harm to the patient.Manufacturer response for catheter, percutaneous, quick-cross (per site reporter), will follow up.

• Brand Name: QUICK-CROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 19380552
• Report Number: 19380552
• Device Sequence Number: 15379395
• Product Code: DQY
• UDI-Device Identifier: 00813132029364
• UDI-Public: (01)00813132029364(11)231205(17)251205(10)F7523M05A
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/02/2024
• Report Date (Section F): 05/02/2024

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: 518-036-B
• Device Catalogue Number: 518-036
• Device Lot Number: F7523M05A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Date Report Sent to FDA: 05/02/2024