MAUDE Adverse Event Report: SPECTRANETICS CORP TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number	414-151
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Turbo elite laser atherectomy catheter was kinked and got stuck to the wire while inside patient.No injury occurred.Fda safety report id # (b)(4).

• Brand Name: TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): SPECTRANETICS CORP; colorado springs CO 80921
• MDR Report Key: 12032342
• Report Number: MW5101982
• Device Sequence Number: 4198635
• Product Code: PDU
• UDI-Device Identifier: 00813132024710
• UDI-Public: 00813132024710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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: 03/25/2022
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY20C16A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1