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

Model Number	518-036
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.A5) patient ethnicity - not available from facility.B6) relevant tests/laboratory data - not available from facility.H3) the quick-cross was returned for evaluation.Visual inspection found all 3 marker bands missing but impressions are present of where the marker bands were originally crimped.Additionally, a kink was noted 20 mm from the distal tip and the encapsulation had been ripped away.H6) based on device evaluation and investigation, the probably cause of this failure has been determined to be use-related.Historically, the manufacturer has seen this failure when the force required to advance and maneuver is greater than the force that the working length can accommodate.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.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a left iliac artery.A spectranetics quick-cross support catheter was used to attempt to cross the lesion; however, the marker band became dislodged in the patient.A stent was placed to jail/tack the marker band to the vessel wall.A second quick-cross was used to complete the procedure.This report captures the quick-cross marker band that detached and remained in the patient, potential for harm.

• 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 24737371
• Report Number: 3007284006-2026-00110
• Device Sequence Number: 21149587
• Product Code: DQY
• UDI-Device Identifier: 00813132029364
• UDI-Public: (01)00813132029364(11)250113(17)270113(10)0303377501
• 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
• Report Date (Section B): 03/30/2026

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 Model Number: 518-036
• Device Catalogue Number: 518-036
• Device Lot Number: 0303377501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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: CORDIS 5F AVANTI PLUS INTRODUCER SHEATH; TERUMO 0.035 ANGLED TIP GLIDEWIRE GUIDEWIRE; TERUMO 5F TRP GLIDECATH GUIDE CATHETER
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White