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

Model Number	420-159
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient''s date of birth, age unk, patient''s weight unk, relevant tests/laboratory data unk.The turbo elite device was returned for evaluation.A kink was observed approximately 38 inches from the distal tip.Visual inspection found the distal tip was completely charred, resulting in protruding/sharp edges in the area.The outer jacket was melted at the base of the distal band resulting in slight deformation.No other damage to the catheter was observed.This has been determined to be a use related failure/failure to follow instructions.In the spectranetics ifu, it states that saline must be infused throughout the entire atherectomy procedure.The burnt epoxy at the turbo elite''s distal tip is indicative of lack of hydration during the procedure.If saline is not present during lasing, the distal tip of the device may become burnt.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.
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 a spectranetics 2.0 turbo elite laser atherectomy catheter to treat the patient, successfully completing one pass through the lesion, and then removed from the patient.As the device was being prepared for re-insertion into the vessel, the turbo elite faulted and damage was observed at the distal tip.Another catheter was used to complete the procedure with no reported patient harm.During device evaluation and investigation, protruding/sharp edges were observed at the device''s distal tip.This event captures the turbo elite with protruding/sharp edges, potential for harm.
Additional Manufacturer Narrative
G3): additional information received on 16 mar2023.H6): based on the additional information, the physician followed the ifu by adequately flushing during the procedure.Further investigation determined that the difficulty of hydration reaching the treatment site was due to the chronic total occlusion (cto) lesion, resulting in the damage observed at the turbo elite''s distal tip.Investigation conclusions code corrected to 50 (from 61 and 18).The cause of the reported failure was related to the patient''s condition, not use related (as captured in the initial mdr).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.
Event or Problem Description
Additional information was received 16mar2023: the turbo elite was flushed with an adequate amount of saline through the sheath, per the ifu.

• 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 ; 719447-2465
• MDR Report Key: 16507186
• Report Number: 1721279-2023-00036
• Device Sequence Number: 3301969
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)241215(10)FBH22M09A
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 12/15/2024
• Device Model Number: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: FBH22M09A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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: COMMAND 0.014 GUIDE WIRE.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; TERUMO 6F INTRODUCER SHEATH.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White