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

Model Number	414-151
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth unavailable.Patient age unavailable.Patient weight unavailable.
Event or Problem Description
A peripheral laser atherectomy procedure commenced to treat lesions in the distal popliteal artery and in the anterial tibial (at) artery.A spectranetics turbo elite laser atherectomy catheter was used to treat the patient.It was reported that the lesion in the distal popliteal artery was treated successfully and the turbo elite device performed as intended.The physician then proceeded to perform a laser atherectomy in the long at artery.A small kink was noticed on the far distal end of the guide wire, but the physician was able to complete a pass through the lesion at 40/40 fluence.The physician reportedly pulled the laser catheter back and then proceeded to perform another pass through the lesion at 60/60 fluence.However, while lasing and advancing the laser catheter, the physician had noted some resistance and then noticed a kink in the laser fiber outside the body, towards the proximal end of the device.The rep reported seeing red light coming out of the kinked area of the laser catheter.The device was removed from the body, and a new laser catheter was used to successfully finish the case with no reported patient harm.Although the turbo elite device is not being returned for evaluation, this event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation, per the report of the event received by the manufacturer.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10426046
• Report Number: 1721279-2020-00175
• Device Sequence Number: 3093779
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)220323(10)FAY20C19A
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• 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): 08/05/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2022
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY20C19A
• 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: 08/05/2020
• Initial Report FDA Received Date: 08/19/2020
• 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