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

Model Number	420-006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned, and evaluated by a cross functional team on (b)(6) 2020.A breach in the device's outer jacket and broken/darkened fibers were observed at 86cm proximal of the device's distal tip.The device's inner lumen was intact, but slightly darkened.There was no other damage noted to the device.Historically, the manufacturer has seen this failure occur while the catheter is being manipulated.This manipulation causes the device's fibers to break.While using the laser with broken fibers, laser energy is then directed into the device's outer jacket in the location of the broken fibers, causing a breach to the outer jacket.This failure has been determined to be use related.
Event or Problem Description
It was reported on (b)(6) 2020 to a philips representative that a peripheral vascular procedure commenced on (b)(6) 2020 to treat a chronic total occlusion (cto) of the patient's mid superficial femoral artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During the procedure, it was reported that the procedure was completed using the turbo elite device; however, it was also reported that the casing of the catheter was destroyed during use (no further detail was provided, and the philips representative reporting the event did not attend the procedure).Upon return of the device to the manufacturer and subsequent evaluation that took place on (b)(6) 2020, the team discovered a breach to the device's outer jacket, making it a reportable event due to the potential for exposure to manufacturing materials as well as inadvertent exposure to laser energy/radiation.The patient survived the procedure and there was no reported patient injury.

• 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: 10800968
• Report Number: 1721279-2020-00224
• Device Sequence Number: 19744272
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)220623(10)FBA20F15A
• 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): 09/24/2020

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: 06/23/2022
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA20F15A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• 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