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

Model Number 518-034

Device Problem Material Separation (1562)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 10/19/2018

Event Type  Injury  

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 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
• Type of Device: QUICK-CROSS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8062418
• MDR Text Key: 126933493
• Report Number: 1721279-2018-00161
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20813132020655
• UDI-Public: 20813132020655
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K033678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/22/2018

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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention