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

Model Number	518-034
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient demographics were requested, but site declined to provide.The device has been returned for evaluation, but evaluation has not yet been performed.
Event or Problem Description
A (b)(6) representative reported that when prepping the spectranetics quick-cross support catheter 518-034 for use in a peripheral atherectomy procedure the physician wanted to exchange a cordis sv-5.018 guidewire down to a.014 wire.The quick-cross was handed off, flushed by the scrub nurse, and put on the wire.He advanced the quick-cross up the wire so the physician could reach it and then the physician took control of advancing the catheter.After a few centimeters the catheter got stuck on the wire.Then the physician told the scrub nurse to remove the catheter off the wire.As the nurse was taking it off it snapped leaving a short segment of the distal tip on the wire.The broken piece was then removed off the wire without any problems.A different type of catheter was used to complete the exchange.All this happened within 100cm of the back end of the 300cm wire.It never entered the patient and it didn¿t cause loss of guidewire position.No harm to patient.Procedure was completed with another catheter.
Additional Manufacturer Narrative
Device evaluation: the quick-cross device was evaluated on (b)(6) 2018.Visual and microscopic evaluation was completed.It appears from the evaluation the quick-cross device became compressed onto the guide wire, as being accordioned.When the physician then attempted removal, the device separated from itself.

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Common Device Name: QUICK-CROSS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8057655
• Report Number: 1721279-2018-00160
• Device Sequence Number: 19312978
• Product Code: DQY
• UDI-Device Identifier: 00813132020651
• UDI-Public: 00813132020651
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K033678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018
• 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?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005