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

Model Number	423-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As part of a japan turbo postmarket study, a peripheral atherectomy procedure commenced to treat an in-stent restenosis (isr) in the patient''s left superficial femoral artery (sfa) and popliteal artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter (along with non-drug coated and drug coated balloon catheters, and a stent graft).After use of the turbo elite, angiography findings showed thrombosis.The thrombosis was not treated and the physician completed the procedure using a plain old balloon angioplasty (poba).It is unk where the thrombosis originated, and it was not confirmed whether thrombosis was present pre-procedure.This report is being submitted out of an abundance of caution, capturing the turbo elite device which was being used when thrombosis was discovered.There was no alleged malfunction of the turbo elite device in use during the procedure.
Additional Manufacturer Narrative
Patient''s date of birth unk.Relevant tests/laboratory data unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.Although thrombus is a known risk of complication with use of the turbo elite device, the cause of the thrombus cannot be established.It has not been determined and cannot be confirmed that the turbo elite caused or contributed to the thrombus due to insufficient information.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
This event is no longer reportable for the turbo elite device creating or contributing to a thrombosis.Per additional information received, the physician reconsidered the event and determined there was no arterial thrombosis.
Additional Manufacturer Narrative
B5: this event is no longer reportable after further information was received.G3: further information was received from the physician on 19dec2022.H6: based on physician''s reconsideration, this event is no longer reportable.H6 codes submitted on the initial mdr are no longer applicable; hecc code 4582 replaces 4440; conclusions code 67 replaces 4315.The turbo elite device did not cause or contribute to a thrombus during the procedure.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: SPECTRANETICS 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
• MDR Report Key: 15888078
• Report Number: 1721279-2022-00214
• Device Sequence Number: 14713345
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)230730(10)FBC21G27A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 07/30/2023
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC21G27A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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 WIRE MANUFACTURER AND SIZE UNK; INTRODUCER SHEATH MANUFACTURER AND SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 38 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian