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

Model Number	420-006
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dob/age unavailable, sex unavailable, weight unavailable, ethnicity unavailable, relevant testing unavailable, other relevant history unavailable, serial# unavailable.Manufacture has requested further information multiple times with no follow up received from company representative, health professional or user facility.
Event or Problem Description
A peripheral atherectomy procedure commenced using a spectranetics turbo elite device.Procedure indication is unavailable from the facility.During use of the turbo elite device the physician reported that the device had a small crack in the devices working length.The physician also noticed a red light coming out of the device where that crack in the device was located.A new turbo elite was used to complete the laser atherectomy without any further issues.The patient was successfully treated without any reported injury.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: 9869341
• Report Number: 1721279-2020-00056
• Device Sequence Number: 11501214
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)211011(10)FDA19K10A
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 02/24/2020
• 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: 10/11/2021
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FDA19K10A
• 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: 02/24/2020
• Initial Report FDA Received Date: 03/23/2020
• 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