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

Model Number 420-006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

Vascular intervention case to treat in stent restenosis.Despite multiple attempts with increased energy and rate to treat, the lesion the turbo elite would not progress.The physician removed the catheter and upon inspection noted that the outer jacket approximately 30cm from the distal tip was compromised.The medical professionals in the room believed that the device may have gotten caught on a stent strut causing the damage.The patient was treated with a pta balloon and deb balloon.There was no injury to the patient.This report is being submitted to reflect on the risk of patient exposure to manufacturing materials in the event of recurrence.The procedure was completed using a ( one attempt with a vascutrac could not cross ) pta balloon followed by a deb.

Manufacturer Narrative

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Manufacturer Narrative

The engineering team was able to confirm damaged device tubing and exposed fibers 31.5 inches from the distal tip of the catheter.The failure described in this adverse event is the result of an abnormally complex procedure.There is no allegation from the physician or evidence of a product malfunction.

Manufacturer Narrative

The patient code has been updated to capture the inadvertent exposure to laser energy/radiation.

• 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: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 4547493
• MDR Text Key: 5517113
• Report Number: 1721279-2015-00031
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2015

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?: No
• Device Operator: Physician
• Device Expiration Date: 08/05/2016
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA14H05A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 02/25/2015
• Supplement Dates Manufacturer Received: Not provided; 08/21/2017
• Supplement Dates FDA Received: 03/27/2015; 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• 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: UNKNOWN GUIDEWIRE
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 125