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

Model Number 423-001

Device Problems Thermal Decomposition of Device (1071); Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation: biological material was seen on the device tip.The band had shifted but was present on the device.A breach to the jacket was seen, causing a potential for exposure to manufacturing materials or laser energy.

Event Description

Vascular intervention case to treat a cto of the sfa.Turbo elite laser was placed over a spider filter wire.The laser sheath was activated while on a stent strut over a period of time which may have caused the marker tip to burn or turn into char.No injury occurred to the patient and the patient was discharged as planned.This report is being made in response to recurrence as well as potential for inadvertent exposure to laser energy (see device evaluation).

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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6323915
• MDR Text Key: 67211489
• Report Number: 1721279-2017-00023
• 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
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/09/2018
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC16M09B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2016
• 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: COVIDIAN SPIDER FILTER WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS QUICK CAT ASPIRATION CATHETER; SPECTRANETICS QUICK CROSS SUPPORT CATHETER
• Patient Outcome(s): Other