MAUDE Adverse Event Report: SPECTRANETICS CORPORATION 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 Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This event is no longer reportable for unintended radiation exposure - potential for harm.Per the returned device analysis, no breach to the outer jacket was observed.
Additional Manufacturer Narrative
B5): this event is no longer reportable after device evaluation and investigation completed.D4): device serial number populated.G3): the device evaluation and investigation were completed 15may2024.H3): the turbo-elite was returned for evaluation.Visual inspection found a wrinkle in the outer jacket, 33 cm distal to the bifurcate.In this area, one broken fiber was noted, but there was no breach to the outer jacket.No other device damage was observed.H6): based on the device evaluation and investigation, the cause of the catheter damage could not be established.Medical device problem code corrected to 2976 (from 1562).Hecc code corrected to 4582 (from 4565).Investigation findings code replaced with 3243 (from 3233).Investigation conclusions code replaced with 4315 (from 11).All other codes from the initial mdr remain applicable.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.
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 (indication for procedure, lesion location unk).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.The procedure was completed with the turbo-elite device; however, upon inspection, fibers were visible in the mid-proximal portion of the catheter.There was no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.

• 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: 19282397
• Report Number: 3007284006-2024-00093
• Device Sequence Number: 20422680
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)250802(10)FAY23G13A
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/21/2024

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: 08/02/2025
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY23G13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2024
• 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: Not provided
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: GUIDE CATHETER MANUFACTURER/TYPE/SIZE UNK; GUIDE WIRE MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/TYPE/SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown