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

Model Number	420-050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient''s date of birth unk.D4): device serial number 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-power 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 on (b)(6) 2023 (as part of a japan turbo pms study) to treat a moderately calcified lesion in the proximal superficial femoral artery (sfa).The patient had a large amount of baseline blood clots/thrombosis present prior to the procedure.Multiple devices (guide wire, introducer sheath, guide catheter, spectranetics turbo-power laser atherectomy catheter, non-drug coated and drug-coated balloons) were used during the procedure.However, just after use of the turbo-power catheter, embolization was confirmed at the popliteal artery via angiogram.The thrombus was aspirated with use of a thrombo-aspiration catheter, with revascularization confirmed afterwards.The angiogram showed nothing after use of plain old balloon angioplasty (poba), and stenosis improved from 100% to 50%.The patient survived the procedure and was discharged from the hospital the following day.Per philips physician assessment, embolization of baseline thrombus can occur when any device is manipulated through the thrombus, including a wire, laser catheter or balloon.This report captures the turbo-power catheter when, after use, embolization was discovered via angiogram, requiring intervention.There was no alleged malfunction of the turbo-power catheter in use during the procedure.

• Brand Name: TURBO-POWER 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: 18455746
• Report Number: 3007284006-2024-00003
• Device Sequence Number: 3114717
• Product Code: MCW
• UDI-Device Identifier: 00813132026783
• UDI-Public: (01)00813132026783(17)240929(10)FTS22J16A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2024

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: 09/29/2024
• Device Model Number: 420-050
• Device Catalogue Number: 420-050
• Device Lot Number: FTS22J16A
• 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
• Initial Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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: DRUG COATED BALLOON(S) MANUFACTURER UNK.; GUIDE CATHETER MANUFACTURER/TYPE/SIZE UNK.; GUIDE WIRE MANUFACTURER/TYPE/SIZE UNK.; INTRODUCER SHEATH MANUFACTURER/TYPE/SIZE UNK.; NON-DRUG COATED BALLOON(S) MANUFACTURER UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian