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

Model Number	414-159
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly calcified lesion in the patient's mid popliteal artery.A spectranetics turbo elite laser atherectomy catheter was used to treat the patient.After the procedure was completed successfully, it was noticed that the turbo elite was sliced or coming apart.The procedure was completed successfully with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• 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
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15108431
• Report Number: 1721279-2022-00144
• Device Sequence Number: 11799839
• Product Code: MCW
• UDI-Device Identifier: 00813132024727
• UDI-Public: (01)00813132024727(17)240519(10)FBF22E09A
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2022

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: 05/19/2024
• Device Model Number: 414-159
• Device Catalogue Number: 414-159
• Device Lot Number: FBF22E09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI GLADIUS 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White