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

Model Number	414-151
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the mid posterior tibial (pt) artery.The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that the turbo elite device could not cross the lesion.When the device was removed from the patient, they noticed the back end of the catheter was melted and fibers exposed.Photo returned to the manufacturer confirmed the report.A.9 turbo elite device was used to complete the procedure with no reported patient harm.Based on the photos provided, this event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
Patient's date of birth and age unk, patient's gender unk, patient's weight unk, patient's race/ethnicity unk, relevant tests/laboratory data unk, other relevant history unk.The device was discarded, thus no investigation could be completed.Photo provided to the manufacturer showed deformation and separation of the device's outer jacket, being held together by exposed fibers within the device.With no device evaluation possible, the cause of the failure cannot be established.

• 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: 12733605
• Report Number: 1721279-2021-00209
• Device Sequence Number: 1454919
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)230504(10)FAY21D23A
• 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): 10/06/2021

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: 05/04/2023
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY21D23A
• 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: 10/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MPA GUIDE CATHETER MODEL/SIZE UNK; SPARTACORE 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH