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

Model Number 518-038

Device Problems Break (1069); Entrapment of Device (1212); Difficult To Position (1467); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2014

Event Type  malfunction  

Event Description

This was a peripheral vascular intervention case to treat an sfa lesion.A quick cross catheter was used during the procedure and got caught on calcium (per physician) and could not be maneuvered.The physician pulled the quick cross trying to remove the catheter and a piece of the catheter broke off inside the patient's vasculature.The physician attempted to snare the quick cross out of the body, however, he was unable to pass the snare through the calcium.The procedure was aborted when the snare could not be advanced.The piece of the quick cross remains in the patient's vasculature.The patient was discharged per operative plan.

• Brand Name: SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Type of Device: QUICK-CROSS
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 3930163
• MDR Text Key: 4583077
• Report Number: 1721279-2014-00112
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/04/2015
• Device Model Number: 518-038
• Device Catalogue Number: 518-038
• Device Lot Number: FQR13F04A
• Other Device ID Number: M204518038198010615FQR13F04A9Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 77 YR