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

Model Number	518-038
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3/h6): the device was not returned, thus no investigation could be completed.However, per clinical assessment, the quick-cross likely separated due to becoming stuck in the severely calcified arterial segment.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 severely calcified lesions in the common iliac artery.The physician chose a spectranetics quick-cross support catheter, and entering from a contralateral approach, multiple attempts were made to cross the lesion, but were unsuccessful.The catheter was pulled back for removal; however, it separated in the region of the proximal marker.Access was gained on the same side, and the separated portion was successfully retrieved via snare, with no reported patient harm.Another quick-cross was used to complete the procedure.This report captures the quick-cross which separated, requiring intervention for retrieval.
Additional Manufacturer Narrative
D2/g): manufacturer name and contact site name corrected from the spectranetics corporation to philips image guided therapy corporation.D9): device was returned to the manufacturer 26jun2023.D10): concomitant device corrected to second quick-cross support catheter, removing the name spectranetics.G): site name corrected from spectranetics to philips image guided therapy corporation.H3): the quick-cross was returned in two pieces, with a break observed 81 mm from the distal tip, and the most proximal marker band was missing.Further information confirmed the proximal marker band was removed from the patient while retrieving the remaining portion of the quick-cross.Striations were observed in the broken piece of the device and the distal tip was crushed.An unknown piece of fibrous material was noted near the break, blocking the inner lumen.With a 0.035¿ laboratory guidewire fed through the inner lumen, the unknown material was removed and determined to be biologics, gauze, and water.No design, process or use related failure was identified.H6): from the initial mdr: conclusions code 67 is no longer applicable; the device was returned to the manufacturer.Conclusions code 50 remains applicable.Based on the evaluation and investigation, it is likely that target lesion morphology made it difficult to withdraw the device from the patient, resulting in the damage observed, as stated 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: 17172987
• Report Number: 1721279-2023-00105
• Device Sequence Number: 12628021
• Product Code: DQY
• UDI-Device Identifier: 00813132029388
• UDI-Public: (01)00813132029388(11)230112(17)250112(10)F7723A12A
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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: 01/12/2025
• Device Model Number: 518-038
• Device Catalogue Number: 518-038
• Device Lot Number: F7723A12A
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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: ABBOTT 5F 11 CM INTRODUCER SHEATH.; SECOND QUICK-CROSS SUPPORT CATHETER.; SECOND SPECTRANETICS QUICK-CROSS SUPPORT CATHETER.; TERUMO 0.035 SS ANGLE GLIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White