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 Codes	Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was requested, but site declined to provide.Visual inspection of the returned device confirmed the end is missing, tubing is torn/ripped possibly pulled at an angle.Length of returned catheter is 121cm.
Event or Problem Description
A philips representative reported that during a peripheral atherectomy procedure for chronic total occlusion of the anterior tibial artery about 9cm of the quickcross support catheter (b)(4) device broke off inside the patient when attempting to cross the lesion.They were not able to remove the remaining piece from the patient.Fragment is still inside the patient's vessel.No further intervention or treatment is planned.

• 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: 8062418
• Report Number: 1721279-2018-00161
• Device Sequence Number: 11114216
• Product Code: DQY
• UDI-Device Identifier: 20813132020655
• UDI-Public: 20813132020655
• Combination Product (Y/N): Y
• Initial Reporter State: DC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2019
• Device Model Number: 518-034
• Device Catalogue Number: 518-034
• Device Lot Number: FQU17D19A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• 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: 10/22/2018
• Initial Report FDA Received Date: 11/12/2018
• 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; Required Intervention
• Date Report Sent to FDA: 01/01/2005