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	Foreign Body Embolism (4439)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient's date of birth unk.H3): a portion of the device was discarded, and two marker bands remained in the patient, thus no investigation could be completed.H6): based on the complaint details, this has been determined to be a use related failure.The quick-cross device became stuck within the subintimal area of the cfa, requiring pulling to remove the device.Per the spectranetics instructions for use (ifu), the device is intended for intravascular use only, and warns the catheter should not be advanced through an area of resistance.Additionally, embolism is a known risk of complication with use of the quick-cross.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 severely calcified lesion in the distal common femoral artery (cfa).A philips quick-cross support catheter was advanced subintimally (within the subintimal layer of the artery) and became stuck.The catheter was pulled and the two most distal marker bands detached from the shaft, resulting in embolism.The marker bands could not be retrieved; therefore, a stent was used to tack the marker bands within the vessel wall.The patient survived the procedure.This report captures the quick-cross marker bands which detached within the patient requiring intervention, but unable to be retrieved.
Additional Manufacturer Narrative
G3): on 11jun2024, philips received an email from fda, informing the manufacturer that the quick-cross device identification information (provided in the initial mdr) contains discrepancies from what is listed on the fda gudid website.D4): upon further review, it was determined that the udi submitted in the initial mdr was incorrect.The following correction was made: primary id portion of the udi was updated to (b)(4).The remainder of the udi remains applicable.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: 17987701
• Report Number: 3007284006-2023-00048
• Device Sequence Number: 12808316
• Product Code: DQY
• UDI-Device Identifier: 00813132029371
• UDI-Public: (01)00813132029371(11)230711(17)250711(10)F7623G11A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/20/2024

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: 07/11/2025
• Device Model Number: 518-037
• Device Catalogue Number: 518-037
• Device Lot Number: F7623G11A
• Was Device Available for Evaluation?: No
• 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: 10/23/2023
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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/SIZE UNK.; INTRODUCER SHEATH MANUFACTURER/SIZE UNK.; TERUMO 0.035 GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American