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	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient''s date of birth unk.B6): relevant tests/laboratory data unk.H3): the device was discarded, thus no investigation could be completed.H6): embolism 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 100% occluded lesion in the left proximal superficial femoral artery (sfa).Prior to the procedure, it was reported that a distal embolic protection device was placed within the patient.Multiple devices (spectranetics turbo-elite laser atherectomy catheter, spectranetics turbo-power laser atherectomy catheter, and drug coated balloon) were used to treat the patient.It was not reported that angiograms were taken after use of the turbo-elite; however, immediately after use of the turbo-power, angiograms revealed a new embolization, despite the embolic protection device being in use.The physician reported the embolization as a peripheral vascular infarction, but no further detail was available, and no intervention was performed after the embolization was discovered.The procedure continued with a plain old balloon angioplasty (poba); angiograms were taken immediately after use of poba as well, with the embolization remaining.A kaneka corporation thrombuster aspiration catheter was used after poba to remove the embolization, and the procedure was completed, with the occlusion being reduced from 100% to 25%.The patient was discharged on (b)(6) 2023.Subsequently, it was reported that 14 days post the initial procedure, the patient died on (b)(6) 2023.The cause of death is unk, as there is no information available to confirm that use of the turbo-power caused the patient's death.This event is being reported out of an abundance of caution, to capture the turbo-power when embolization was detected immediately after its use, with no intervention implemented at that time.This report does not capture the patient's death since the patient died 14 days post-procedure.There was no alleged malfunction of any spectranetics devices 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: 17652038
• Report Number: 3007284006-2023-00020
• Device Sequence Number: 7380787
• 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: K222837
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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: 08/30/2023
• 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 MANUFACTURER/SIZE UNK; GUIDE CATHETER MANUFACTURER/SIZE UNK; GUIDE WIRE MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TURBO-ELITE LASER CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian