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

Model Number	518-037
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	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An atherectomy procedure commenced to treat a calcified lesion.A philips quick-cross support catheter was used to treat the patient.During removal of the quick-cross from the patient, the proximal marker band was discovered to be overlapping with the middle marker band.The procedure was completed with no reported patient harm.This event is being reported out of an abundance of caution, which captures the quick-cross marker bands that detached but remained on device, potential for harm.
Additional Manufacturer Narrative
H3): the quick-cross was returned for evaluation.Visual inspection found the proximal and middle marker bands were crushed, and had detached from the original location, but remained on the device.The proximal marker band was bent and lifted from its proximal end, creating a sharp edge, and scratches were visible on the proximal and middle marker bands.The distal marker band was slightly crushed but remained attached at its original location.During functional testing, an 0.035" laboratory guide wire was loaded from the quick-cross hub, met resistance approximately 31 cm from the distal end, and was unable to pass through the device.H6): based on the device evaluation and investigation, it has been determined that the damage was related to the patient condition.The proximal marker band appears to have caught on calcification which moved the proximal and middle marker bands distally.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
This case was reviewed and investigated according to the manufacture¿s policy.Upon further review, it was determined that the udi listed in the initial mdr was incorrect.Block d4) the udi was updated to (b)(4).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: 18636893
• Report Number: 3007284006-2024-00024
• Device Sequence Number: 7763436
• Product Code: DQY
• UDI-Device Identifier: 00813132029371
• UDI-Public: (01)00813132029371(11)231004(17)251004(10)F7623K04A
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Expiration Date: 10/04/2025
• Device Model Number: 518-037
• Device Catalogue Number: 518-037
• Device Lot Number: F7623K04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: GUIDE CATHETER MANUFACTURER/TYPE/SIZE UNK.; GUIDE WIRE, MANUFACTURER/TYPE/SIZE UNK.; INTRODUCER SHEATH MANUFACTURER/TYPE/SIZE UNK.
• Patient Sex: Unknown