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

Model Number	414-151
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer but the evaluation has not yet begun.A supplemental mdr will be submitted upon completion of the device evaluation and investigation.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 calcified lesion in the superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.When the turbo-elite was plugged into the laser system during preparation for use, holes were observed in the outer jacket, with laser light being emitted from the areas.Use of the catheter was discontinued, and another turbo-elite of the same size was used to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
D4): device serial number populated.G3): the device evaluation and investigation were completed 23may2024.H3): visual inspection found a 5 cm segment of the outer jacket severely twisted, just distal to the bifurcate, with multiple broken fibers in the area.A breach was detected 5 cm distal to the bifurcate, in the area of the twisted outer jacket.Throughout the working length, heavy biologics were observed.H6): based on the device evaluation and investigation, the cause of the damage could not be established.Investigation findings code 3243 replaced (from 3221).Investigation conclusions code 4315 replaced (from 11).All other codes remain applicable as listed 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.

• Brand Name: TURBO-ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 19281862
• Report Number: 3007284006-2024-00094
• Device Sequence Number: 6358981
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)250821(10)FAY23H08A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/12/2024

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: 08/21/2025
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY23H08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• 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: 05/23/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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: ABBOTT VIPERWIRE 0.014 GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Sex: Unknown