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

Model Number	410-152
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable.
Event or Problem Description
A procedure began to treat a patient using a spectranetics turbo elite device.During preparation for use, the facility reported that the team saw light coming sideways from near the distal tip of the device.The device did not enter the patient; another device was opened, and the procedure was completed successfully with no reported patient harm.This event is being reported due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.

• Brand Name: SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER
• Common Device Name: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7813457
• Report Number: 1721279-2018-00113
• Device Sequence Number: 13768903
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: 00813132024697
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2018
• 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: 02/27/2020
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD18B20A
• 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: 08/06/2018
• Initial Report FDA Received Date: 08/24/2018
• 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