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

Model Number 410-152

Device Problems Smoking (1585); Defective Device (2588); Difficult to Advance (2920)

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

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

During an atherectomy procedure a spectranetics turbo elite catheter was used to treat a lesion.The laser sheath was difficult to advance and the catheter began to smoke.The catheter was removed from the surgical field.A visual defect was noted on the working length of the catheter; however this portion of the device did not come into contact with the patient.The procedure was successfully completed with a subsequent device.This report is to reflect on the potential for exposure to manufacturing materials and inadvertent laser energy.

Manufacturer Narrative

(b)(4).Device evaluation: physical evaluation of the device suggests that this event was caused during the handling of the device during the procedure.There is no indication of a manufacturing issue during the manufacture of this lot of device related to this complaint.

Manufacturer Narrative

Date of this report was corrected to reflect the date that the complaint information was received by the manufacturer.

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; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-200
• MDR Report Key: 6097821
• MDR Text Key: 59775431
• Report Number: 1721279-2016-00165
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140775
• 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,Followup,Followup,Followup,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/26/2018
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBH16H26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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: SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS TURBO-ELITE LASER ABLATION CATHETER
• Patient Outcome(s): Other