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

Model Number	417-152
Medical Device Problem Codes	Collapse (1099); Degraded (1153)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable.
Event or Problem Description
A philips representative was informed of this event on (b)(6) 2020.A peripheral vascular intervention procedure commenced to treat a chronic total occlusion (cto), severely calcified lesion (location of lesion unknown).Crossing the lesion was made by accessing from fem ctranetics turbo elite laser atherectomy catheter was chosen for the procedure.As the physician was lasing, he came upon a heavily calcified area that was difficult to cross.As he gripped the fiber near the sheath being used in the procedure, the fiber reportedly buckled against the sheath and he noticed that a small portion of the device's outer jacket came off of the laser catheter and red light was slightly visible.At that time, the laser catheter was reportedly removed and the case was completed with a balloon.It was reported that the laser catheter was not broken, just buckled, and the portion of the device's outer jacket came off of where the physician was holding the fiber before it enters the sheath.The patient survived the procedure with no reported patient injuries.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: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10311317
• Report Number: 1721279-2020-00143
• Device Sequence Number: 3416945
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)220221(10)FAZ20B17A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 06/24/2020
• 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: 02/21/2022
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ20B17A
• 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: 06/24/2020
• Initial Report FDA Received Date: 07/22/2020
• 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