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

Model Number	518-036
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a non-thrombotic lesion in the mid superficial femoral artery.The patient was experiencing claudication, and had an existing stent present in the area.A philips quick-cross support catheter was used to treat the patient.While using a contralateral approach and crossing behind the existing stent, the quick-cross got stuck, and broke off in two pieces.One portion of the quick-cross was successfully snared; however, the second portion could not be retrieved and was stented within the patient.A second quick-cross was used to complete the procedure.This report captures the quick-cross which separated at the shaft, requiring intervention, with a portion retained in the patient.
Additional Manufacturer Narrative
A2): patient date of birth unk.A3b.): patient gender unk.H3/h6): the quick-cross was not returned, thus no returned product investigation was performed, and the reported failure could not be confirmed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Additional Manufacturer Narrative
D9) the quick-cross device was returned for evaluation on 03mar2025.G3) the device evaluation and investigation was completed on 05mar2025.H3) the quick-cross device was returned in two pieces.The distal section includes one marker (found under the lumen material); measuring approx.6 mm in length.The proximal section includes the luer; measuring approx.111 cm in length.Visual inspection found a stretched lumen material and missing middle and proximal marker bands.Due to the stretched lumen material, the portion length that was retained in the patient and the location/condition of the two missing marker bands could not be determined.Additionally, at the location of the separation, ripped and torn edges were noted.The total length combined is 111.6 cm, which is outside of the measurement spec of 88-92 cm due to stretched lumen material.H6) based on device evaluation and investigation, the root cause cannot be confirmed.However, the probable cause is likely due to the catheter getting stuck on the stent as noted in the complaint details, combined with pulling force, which led to the stretching of the lumen material and ultimately resulted in device separation.Type of investigation code b01 replaced (from b17).Investigation findings code c070603 replaced (from c20).Investigation conclusions code d1001 and d1102 replaced (from d14).All other codes are applicable as listed in the initial mdr.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: QUICK-CROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): PHILIPS IMAGE GUIDED THERAPY CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 21021582
• Report Number: 3007284006-2024-00251
• Device Sequence Number: 9738885
• Product Code: DQY
• UDI-Device Identifier: 00813132029364
• UDI-Public: (01)00813132029364(11)240620(17)260620(10)F7524F20A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2026
• Device Model Number: 518-036
• Device Catalogue Number: 518-036
• Device Lot Number: F7524F20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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: COOK 6F ANSEL INTRODUCER SHEATH.; TERUMO 0.014 GUIDE WIRE.
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American