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

Model Number	417-152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Thrombosis/Thrombus (4440)
Date of Event	07/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Study name: turbo laser pms japan.The device was discarded, thus no investigation could be completed.
Event or Problem Description
This event was part of a postmarket study being conducted in (b)(6).A peripheral atherectomy procedure commenced to treat an in-stent reocclusion (isr) in the patient's left superficial femoral artery.Initially, on (b)(6) 2020, the isr was successfully treated with a spectranetics turbo elite laser atherectomy catheter and non-coated balloon catheter.However, on (b)(6) 2021, isr was again confirmed with no treatment recommended at this time.Then, on (b)(6) 2021, it was confirmed that the patient¿s health did not improve.The physician thought there was no relation between the isr and the turbo elite and the procedure.Approximately two weeks later on (b)(6) 2021, the lesion was treated with a spectranetics turbo elite laser atherectomy catheter and a jade 5.0mm balloon.An ivus catheter was in use during the procedure.Four days later on (b)(6) 2021, acute limb ischemia due to arterial thrombus was confirmed.Finally on (b)(6) 2021, percutaneous transluminal angioplasty was performed with use of plain old balloon angioplasty (poba).The procedure was completed successfully and the patient survived the procedure.This report captures the turbo elite device in use on (b)(6) 2021 that may have caused or contributed to the acute limb ischemia due to arterial thrombus, requiring intervention.There was no alleged malfunction of the turbo elite device in use during the procedure.

• 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): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13553111
• Report Number: 1721279-2022-00029
• Device Sequence Number: 11695995
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)220106(10)FAZ19M23A
• 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
• Report Date (Section B): 01/25/2022

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: 01/06/2022
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ19M23A
• 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: 01/25/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• 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: ABBOTT COMMAND 300 CM GUIDE WIRE SIZE UNK; BOSTON JUPITER 15 GUIDE WIRE SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO 6F DESTINATION 45 CM INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 49 KG