MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER; 1.4 TURBO ELITE (OTW)

Model Number	414-151
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was requested, but unavailable from the site.The device was discarded by the user.Therefore, device evaluation cannot be completed.
Event or Problem Description
A philips representative reported that during inspection of a turbo-elite laser atherectomy catheter 414-151, prior to use in a peripheral atherectomy procedure, a hole was noted in the catheter when attempting to calibrate the device.The device did not enter the patient's body.Another turbo-elite laser atherectomy catheter 414-151 was used to successfully complete the procedure.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 LASER ATHERECTOMY CATHETER
• Common Device Name: 1.4 TURBO ELITE (OTW)
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8011694
• Report Number: 1721279-2018-00153
• Device Sequence Number: 13768744
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: 00813132024710
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 10/01/2018
• 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: 05/26/2019
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY17E24A
• 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: 01/14/2005
• Initial Report FDA Received Date: 10/28/2018
• 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