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

Model Number	423-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned and evaluated by a cross functional team on 21 may 2020.During visual examination of the device, the team observed broken fibers and a breach to the outer jacket located 64cm proximal of the strain relief.Historically, the manufacturer has seen this failure occur while the catheter is being manipulated.This manipulation causes the fibers to became damaged.While using the laser with damaged fibers, energy is directed into the outer jacket, causing a breach to the outer jacket.
Event or Problem Description
A peripheral atherectomy procedure commenced using a spectranetics turbo elite laser atherectomy catheter device.Although requested, procedure indication is unavailable from the facility.During preparation for use with the turbo elite, the physician reported that the device failed calibration.The physician then saw light leaking out of the device approximately one third from the proximal end of the device.It was reported that the device never entered the body.The physician used another device and the case was completed successfully with no reported patient harm.This event is being reported due to the potential for exposure to manufacture materials and inadvertent laser energy/radiation exposure.

• 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: 10081033
• Report Number: 1721279-2020-00112
• Device Sequence Number: 3852904
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)210812(10)FBC19H06A
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 03/31/2020
• 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: 08/12/2021
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC19H06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• 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: 03/31/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005