MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS QUICK-CROSS SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Model Number	518-036
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unavailable.The quick cross device was evaluated on 03oct2019 by a cross-functional team.The catheter was received in two pieces.A portion of the distal tip was detached from the rest of the catheter.The marker band was crushed and the tubing shredded.Damage is consistent with being caught on stent.The other portion of the catheter is stretched out, as if it was pulled (also consistent with being caught on stent).
Event or Problem Description
A philips representative reported during a peripheral atherectomy procedure, the catheter snapped in two within the patient.Patient had previous bilateral iliac artery stents and the right side extended into the aorta.The quick cross catheter became "hung" on the right side stent edge (not in the stent structure) when physician was removing it.With left side common femoral artery (cfa) access, the physician was able to snare the wire from right side into left sheath, placed 5fr 90 cm dilator onto wire, and pushed remaining quick cross catheter out of left side cfa sheath.The physician was able to remove all parts without any issue and another spectranetics quick cross support catheter was used to complete the procedure.No patient injury occurred.
Additional Manufacturer Narrative
This case was reviewed and investigated according to the manufacture¿s policy.Upon further review, it was determined that the information listed in the initial mdr were incorrect.The common device name was updated to catheter, percutaneous (from quick-cross).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: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 9175103
• Report Number: 1721279-2019-00175
• Device Sequence Number: 2591911
• Product Code: DQY
• UDI-Device Identifier: 00813132020675
• UDI-Public: (01)00813132020675(17)210731(10)FQP19G30A
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024
• Report Date (Section F): 01/01/2005

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: 07/31/2021
• Device Model Number: 518-036
• Device Catalogue Number: 518-036
• Device Lot Number: FQP19G30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005