MAUDE Adverse Event Report: Spectranetics Corporation Quick-Cross Support Catheter; Catheter, Percutaneous

Model Number	518-066
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3) the quick-cross was returned for evaluation.Visual inspection found the proximal marker band moved distally next to the middle band, which is approx.54 mm from its expected position.The middle marker band moved approx.4 mm distal to its expected position.The distal marker band is in the correct position.There was no evidence of elongation; however, the tube is pinched 30-50 mm from the distal tip.Original swagging marks are visible in their expected positions, and encapsulation is in good condition.H6) based on device evaluation and investigation, movement of the marker bands was confirmed; however, the cause of the movement could not be established.Type of investigation code b01 replaced (from b17).Investigation findings code c0706 replaced (from c20).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): Spectranetics Corporation; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): Spectranetics Corporation; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; +1(719)447-2465
• MDR Report Key: 50168532
• Report Number: 3007284006-2026-00413
• Device Sequence Number: 13262719
• Product Code: DQY
• UDI-Device Identifier: 00813132029401
• UDI-Public: (01)00813132029401(11)260519(17)280519(10)0303772643
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072750
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 518-066
• Device Catalogue Number: 518-066
• Device Lot Number: 0303772643
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2026
• 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 Sex: Unknown