MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER

Model Number 423-001

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

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

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

The cross functional engineering team examined the device and found broken fiber at damaged location which caused energy to burn through outer jacket.Exposure to manufacturing materials possible related to damage.The device had originally calibrated indicating the device had not been damaged prior to start of the procedure.(b)(4).

Event Description

This case was a peripheral intervention of the sfa.It was reported that a hole developed in working length of the laser catheter causing a fault 03 on the spectranetics excimer laser system.Another spectranetics turbo elite catheter was used to complete the case.No complications were reported.Patient discharged per operative plan.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ABLATION CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 7194472210
• MDR Report Key: 5010869
• MDR Text Key: 24543478
• Report Number: 1721279-2015-00124
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 07/27/2015

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
• Device Operator: Physician
• Device Expiration Date: 12/13/2015
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC13M13A
• Other Device ID Number: SEE H 10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Supplement Dates Manufacturer Received: Not provided; 08/17/2017
• Supplement Dates FDA Received: 03/22/2017; 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• 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