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

Model Number	414-159
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly calcified lesion in the patient's mid superficial femoral artery (sfa).The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.After the physician used the turbo elite device in the patient and was removing the device, he noticed the "outer sheath was torn" and fibers were visible.It was reported that there was difficulty getting the turbo elite device through the sheath and believed that may have been the reason the device was damaged.A new spectranetics turbo elite laser atherectomy catheter was used to finish the procedure, and there was no reported patient harm.This event is being submitted to capture the turbo elite which was found damaged during use and resulted in unintended radiation exposure with 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: 12333209
• Report Number: 1721279-2021-00151
• Device Sequence Number: 4454702
• Product Code: MCW
• UDI-Device Identifier: 00813132024727
• UDI-Public: (01)00813132024727(17)230303(10)FBF21B18A
• 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
• 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): 07/22/2021

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: 03/03/2023
• Device Model Number: 414-159
• Device Catalogue Number: 414-159
• Device Lot Number: FBF21B18A
• 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: 07/22/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1