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

Model Number	417-152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Iatrogenic Source (2498)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age unavailable.Patient date of birth unavailable.Patient gender unavailable.Patient weight unavailable.
Event or Problem 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
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9742168
• Report Number: 1721279-2020-00040
• Device Sequence Number: 16772623
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)211011(10)FAZ19K04A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K140775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005