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

Model Number	518-034
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No patient information was provided on the facility medwatch mw5083367.Initial reporter information was not included on the facility medwatch mw5083367.The device was not returned to the manufacturer for evaluation.
Event or Problem Description
On (b)(6) 2019 a philips post market surveillance employee received the following user facility medwatch from the fda, medwatch mw5083367.Distal tip of catheter broke off during attempt to advance it.Tip retrieved with out incident.
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 was incorrect.The common device name was updated to catheter, percutaneous (from quick-cross).The udi was updated to (b)(4).510(k) number updated to k033678 (from k150201).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: 8395001
• Report Number: 1721279-2019-00032
• Device Sequence Number: 19564581
• Product Code: DQY
• UDI-Device Identifier: 00813132020651
• UDI-Public: (01)00813132020651(17)200703(10)FQU18G03A
• Combination Product (Y/N): Y
• 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: 07/03/2020
• Device Model Number: 518-034
• Device Catalogue Number: 518-034
• Device Lot Number: FQU18G03A
• Was Device Available for Evaluation?: No
• 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: 02/11/2019
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2018
• 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