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

Model Number	423-135-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral vascular intervention case commenced using a spectranetics turbo elite laser atherectomy catheter.During preparation for use, the physician reported having trouble feeding the guidewire through the guide port of the device.The guide port eventually broke causing damage to the catheter.After damaging the catheter, the physician stated a light could been seen coming out through the outer jacket of the device.The procedure was successfully completed with a new device with no reported patient injury.This event is being reported due to the potential for exposure to manufacture materials and inadvertent laser energy/radiation exposure.
Additional Manufacturer Narrative
B5): this section populated with corrected information regarding details of the procedure.G5): corrected to reference the most current 510k number for this device.The previous number populated in the initial mdr was the previous 510k number.This supplemental mdr is submitted to capture the additional information regarding the reported cause of the device failure, and to correct the 510k number.The device is not available to the manufacturer for evaluation.H6) evaluation codes remain the same as in the initial mdr.
Event or Problem Description
In the initial mdr submitted for this event, it was reported that "the physician reported having trouble feeding the guidewire through the guide port of the device.The guide port eventually broke causing damage to the catheter." upon further discussion on 25 june 2020 with the philips representative who was present at the case, it was discovered that the damage to the device was not caused by a guidewire.Reportedly, although the breach to the outer jacket of the device may have been at the area of the laser catheter where the guide wire is inserted (cannot confirm because the device is not being returned), an outer sheath (manufacturer unknown) was being used in a contralateral approach to treat the patient.It was reported that the physician was able to get through the first portion of the outer sheath but at the bifurcate, it became difficult to advance the device.It was at that time that the device was discovered to be damaged.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ARTHERECTOMY CATHETER
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10183976
• Report Number: 1721279-2020-00129
• Device Sequence Number: 14129784
• Product Code: MCW
• UDI-Device Identifier: 00813132024796
• UDI-Public: (01)00813132024796(17)210429(10)FBL19D26A
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 05/28/2020
• 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: 04/29/2021
• Device Model Number: 423-135-01
• Device Catalogue Number: 423-135-01
• Device Lot Number: FBL19D26A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 01/01/2005