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

Model Number	410-152
Medical Device Problem Codes	Crack (1135); Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Radiation Exposure, Unintended (3164)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight unavailable.
Event or Problem Description
A peripheral vascular intervention procedure commenced to treat a chronic total occlusion (cto) in the patient's right anterior tibial (at) artery.During the procedure, the rep reported the spectranetics turbo elite could not cross the calcified lesion.When the device was removed from the patient, it was reported that the device's working length ''buckled'' and cracked the device's outer jacket, near where the physician was holding onto the device.A second device was used to complete the procedure.No user or patient harm was reported.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: TURBO ELITE
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9267998
• Report Number: 1721279-2019-00191
• Device Sequence Number: 419212
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)210805(10)FBD19G31A
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2019
• 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: 08/05/2021
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD19G31A
• 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: 10/17/2019
• Initial Report FDA Received Date: 11/01/2019
• 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
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005