MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS TURBO ELITE

Model Number 420-006

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Thrombus (2101)

Event Date 11/25/2016

Event Type  Injury  

Event Description

This procedure was to treat an occlusion of the medial sfa of approximately 3 cm in length.The lesion was treated with a spectranetics turboelite laser ablation catheter, which opened up a channel of 3mm with stenotic areas.Two balloons were used to optimize the result.Angiogram of the distal vessels showed vessels without contrast.The physician aspirated thrombus, however angiogram showed increasing embolization of the distal btk vessels.Several poba of all btk vessels were used as well as a stent.Plantar blood circulation was achieved.The patient survived the procedure.It is unclear if the spnc turboelite was a contributory factor to the ae, we are reporting as such and will continue investigation and file follow up report accordingly.

Manufacturer Narrative

Device evaluation; the catheter tip showed signs of heavy use.One dead fiber seen, no damage to working length of catheter.Review did not indicate any issues during the manufacture of this lot of device related to this complaint.This is related to the heavy use.(b)(4).

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
• 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 ; 719447-257
• MDR Report Key: 6191072
• MDR Text Key: 62911552
• Report Number: 1721279-2016-00192
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K140775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/04/2018
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA16K04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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: BARD LUTONIX DCB; POBA MFR. UNKNOWN; SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS QUICK-CROSS SUPPORT CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR