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

Model Number 417-152

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Iatrogenic Source (2498)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Patient age unavailable.Patient date of birth unavailable.Patient gender unavailable.Patient weight unavailable.

Event Description

A peripheral vascular intervention procedure commenced.The physician was using a spectranetics turbo elite laser atherectomy catheter to treat a left popliteal lesion from a pedal access site.The laser impacted the distal cap of the occlusion; however, instead of crossing the lesion, the turbo elite unintentionally deflected off of the plaque and created a subintimal channel which then went submedial.The case was then aborted with no additional intervention required.There was no alleged malfunction of any spectranetics devices used in the procedure.Upon further investigation of this event and with consultation from philips senior medical advisor on (b)(6) 2020 to discuss the case detail of subintimal and submedial channels being created by the turbo elite device, it was concluded that although there are procedures performed in which channels are created in this vessel space in order to restore blood flow, this was an unplanned event.Although there was no patient injury in this event, this report is being submitted due to the potential for serious injury if this event was to recur.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9742168
• MDR Text Key: 180912364
• Report Number: 1721279-2020-00040
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)211011(10)FAZ19K04A
• Combination Product (y/n): Y
• 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
• Report Date: 01/01/2005,01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ19K04A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 02/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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
• Patient Outcome(s): Other