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

Model Number	420-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient''s date of birth unk, b6): relevant tests/laboratory data unk, b7): other relevant history unk, h3): the device was discarded, thus no investigation could be completed.H6): embolization is a known risk of complication with use of the turbo-elite device.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 plaque lesion in the mid superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.After the atherectomy was completed, it was discovered that a clot had embolized distally into the patient's tibial arteries.Tissue plasminogen activator (tpa) was administered to dissolve the clot, and the patient survived the procedure.This report captures the turbo-elite in use when an embolism occurred, requiring intervention.There was no alleged malfunction of the turbo-elite device in use during the procedure.
Additional Manufacturer Narrative
D4): upon record review 13sep2024, it was discovered that the device udi had been incorrectly populated in the initial mdr.Udi corrected to: (b)(4).All other fields remain accurate 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: 18271017
• Report Number: 3007284006-2023-00083
• Device Sequence Number: 17117058
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)250921(10)FBA23J11A
• Combination Product (Y/N): N
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2025
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA23J11A
• Was Device Available for Evaluation?: No
• 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: 09/13/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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: CSI SHEPHERD 0.014 GUIDE WIRE; GUIDE CATHETER MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White