MAUDE Adverse Event Report: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER

Model Number 518-034

Device Problems Material Puncture/Hole (1504); Device Damaged by Another Device (2915)

Patient Problem Laceration(s) (1946)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.Through visual examination of the device, a hole in the device 4 inches from the distal tip was confirmed.The nature of the hole indicated that the puncture occurred from the inside, outward.It was also noted that the working length of the device had a kink in the area where the hole was observed.The damage to the device was caused by the user and/or the use environment, and no defects in the device were noted that could have caused the observed damage.

Event Description

It was reported that during a vascular intervention procedure to treat a lesion in the patient's superficial femoral artery (sfa), the guidewire punctured the device.Reportedly, the wire punctured the working length of the device and perforated the sfa.The injury was repaired by placing stents in the sfa.The procedure was completed and the patient was discharged as planned.

• Brand Name: QUICK-CROSS SUPPORT CATHETER
• Type of Device: QUICK-CROSS
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6504759
• MDR Text Key: 73214798
• Report Number: 1721279-2017-00068
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2017

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: Physician
• Device Expiration Date: 01/21/2018
• Device Model Number: 518-034
• Device Catalogue Number: 518-034
• Device Lot Number: FQU16A20A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: QUICK-CROSS SUPPORT CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention