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

Model Number	410-152
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.Because the device was not returned for evaluation, the cause of the reported damage could not be determined.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a lesion in the distal tibial artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.The report stated that the physician had pedal access to the lesion, as well as access from above.He advanced the turbo elite device from above while holding fairly aggressive back pressure as he attempted to cross the lesion.A few different settings on the turbo elite device were used to attempt to cross the lesion, but were unsuccessful.As the physician was trying to advance the laser, the outer jacket reportedly started to wrinkle and it seemed the device was having a hard time tracking, or possibly getting stuck on the wire, which was a 14 command wire.The philips representative advised the physician to stop and withdraw the turbo elite device from the patient.He was then able to cross the lesion via balloon angioplasty from the pedal access, and the procedure was completed with no reported patient harm.The physician stated he didn't believe the device was defective; he stated he was just being pretty rough with it.The philips representative stated that the catheter had wrinkles present, along with a tear in the device's outer jacket with exposed fibers.She was unsure if the device was also manipulated by the physician and/or tech after it was removed from the patient.This event is being reported due to unintended radiation exposure, potential for harm.

• 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: 12217292
• Report Number: 1721279-2021-00137
• Device Sequence Number: 2840029
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)230428(10)FBD21D20A
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2021

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: 04/20/2023
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD21D20A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR