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

Model Number	518-065
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Material Perforation (2205); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient gender and weight not available from the site.Visual examination of catheter confirmed a hole was present 5mm from the distal tip.Likely cause is the user encountered resistance in the anatomy, the catheter deflected, and the guide-wire continued straight, puncturing the catheter.A couple kinks were found along the catheter as well.
Event or Problem Description
During a peripheral vascular surgery utilizing femoral access, the surgeon stated when using the quick-cross support catheter 518-065, they could not go as low in the leg as wished, past the proximal anterior tibial artery.Also, when taking out the quick-cross they noticed a hole in the catheter above the tip.No device remnants were detected to be left in the patient.The case was successfully completed with a balloon and guide-wire.No impact on patient outcome due to this event.This is being reported due to the potential for serious injury with recurrence.

• 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: 7920057
• Report Number: 1721279-2018-00129
• Device Sequence Number: 19316936
• Product Code: DQY
• UDI-Device Identifier: 00813132020712
• UDI-Public: 00813132020712
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2018
• 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: 06/22/2019
• Device Model Number: 518-065
• Device Catalogue Number: 518-065
• Device Lot Number: FQV17F21A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• 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: 09/04/2018
• Initial Report FDA Received Date: 09/28/2018
• 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