MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER

Model Number 423-135-02

Device Problem Temperature Problem (3022)

Patient Problem Thrombus (2101)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information unavailable.Although thrombus was reported during the procedure, it was reported that the thrombus was as a result of the 35cm in-stent restenosis present within the patient''s superficial femoral artery.

Event Description

During a procedure which was part of an intact study a peripheral vascular intervention commenced to treat in in-stent restenosis (isr)in a superficial femoral artery (sfa).The procedure access approach was contralateral and a 035" stiff terumo guidewire was used.Pre dilation with a balloon was performed before a spectranetics turbo elite device was used.2 passages of the turbo elite were completed at the following fluencies: 25/45 then 60/80.It was reported that the physician paused every 20 seconds as recommended in the form of good use that was reportedly signed by the investigators and users.Post dilation, the guide wire was removed from the device in order to perform thromboaspiration, because thrombus was present distally from the treatment site with no guide wire debris.However, it was discovered that the coating of the guide wire was damaged (melted on 3 cm) with a strong smell of burn in the operating room.No guide debris caused any emboli.There was indeed thrombus but this was reportedly related to the procedure (a 35cm isr).According to the rep, flushing of the device occurred through the sheath and not through the inner lumen of the device.She spoke with the physician after the procedure (she was not present during the procedure), and the physician stated he forgot to decrease the size of the guide wire (as directed in the intact study).It states in the turbo elite training bulletin for use of the turbo elite device in accordance with the turbo elite instructions for use (ifu) for (b)(6) users and company representatives provided (b)(6) 2018, ''when the contralateral approach is used, smaller diameter guide wires are suggested to allow adequate saline infusion at the treatment site''.In addition, it states that ''in any procedure in which a turbo elite device is in use, including in-stent restenosis (isr), the saline bolus/infusion must reach the treatment site during use.Therefore, either through the outer sheath or inner lumen (depending on the approach), there must be room for the saline to reach the treatment site during infusion and bolus.This may require downsizing the guide wire if the saline cannot be infused adequately to reach the treatment site''.Without adequate hydration at the distal tip of the device where laser energy emits, the laser catheter can generate excessive heat buildup, which in turn can adversely affect device materials, components and/or patient vasculature in the area.In this event, there was no reported patient injury and the procedure was successfully completed with use of the turbo elite device.The manufacturer is anticipating a return of the turbo elite device for evaluation but it has not yet been received.

Manufacturer Narrative

Corrected information: the manufacturer was anticipating return of the turbo elite device from france for evaluation.The manufacturer received word on 02 december 2019 that the device was discarded at the facility.The device will not be returned.Device not returned to manufacturer.Method, results and conclusions codes now populated to reflect device not being returned, therefore a cause of the reported device malfunction could not be established.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9365889
• MDR Text Key: 220028282
• Report Number: 1721279-2019-00204
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024802
• UDI-Public: (01)00813132024802(17)210205(10)FBN19A29A
• Combination Product (y/n): Y
• PMA/PMN Number: K170059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: 423-135-02
• Device Catalogue Number: 423-135-02
• Device Lot Number: FBN19A29A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER