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

Model Number	414-151
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned, thus the reported failure could not be confirmed.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 critical limb ischemia due to a moderately fibrous lesion in the distal posterior tibial (pt) artery.A spectranetics turbo elite laser atherectomy catheter was used to treat the patient.During the procedure, red light was observed coming through the outer jacket.Use of the device was discontinued and another catheter was used to successfully complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Event or Problem Description
This event is no longer reportable for unintended radiation exposure, potential for harm.Device evaluation confirmed no breach to the turbo elite''s outer jacket; therefore, no unintended radiation exposure occurred.
Additional Manufacturer Narrative
B5): this event has been determined to no longer be reportable.D9): the turbo elite was returned to the manufacturer for evaluation 23may2023.G3): the device evaluation/investigation were completed (b)(6) 2023.H3): visual inspection found red light emitting from the working length; one broken fiber was apparent underneath the outer jacket (within specification).This area contained no breach to the outer jacket.H6): component and heic codes remain applicable as listed in the initial mdr.Medical device problem code corrected to 1069 (from 1562); a broken fiber was observed, but no breach to the outer jacket occurred.Hecc code corrected to 4582 (from 4565); it was confirmed no unintended radiation exposure occurred.Type of investigation code corrected to 10 (from 4114); the device was returned to the manufacturer for evaluation.Investigation findings code corrected to 3252 (from 3221); a broken fiber was apparent under the outer jacket.Investigation conclusions code corrected to 4315 (from 67); based on the device evaluation and investigation, the cause of the broken fiber could not be established.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): 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: 16956939
• Report Number: 1721279-2023-00078
• Device Sequence Number: 17902572
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)250109(10)FAY23A04A
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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: 01/09/2025
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY23A04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/18/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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: COMMAND GUIDE WIRE SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F INTRODUCER SHEATH
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic