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	Obstruction/Occlusion (2422); Vascular Dissection (3160)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient''s ethnicity/race unavailable.Relevant tests/laboratory data unavailable.The device was discarded, thus no investigation could be completed.
Event or Problem Description
A philips (b)(6) representative became aware on 01 june 2021 that a peripheral atherectomy procedure commenced on (b)(6) 2021 to treat an in-stent occlusion in the proximal, mid and distal region of the superficial femoral artery (sfa) in the patient''s left lower extremity.This event was part of a postmarket study occurring in japan.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.It was reported that lesion was present in the vessel proximal and distal to the stent, as well as being present in the stent itself.It was reported that the turbo elite device successfully lased through the lesion, clearing the obstruction.However, it was reported that after the turbo elite device was used, an acute occlusion was confirmed on angiogram; the report stated that the blood vessels recoiled after applying the turbo elite device to the in-stent lesion.The obstructive lesion outside the stent had not been dilated at that time, and an influx of contrast medium was then present within the sfa, and no laser based blood flow was present on the angiogram image.A wire was then passed through to the occlusion reportedly outside the blood vessel, and the patient was treated with a non-drug coated balloon catheter.However, a grade c dissection was confirmed on angiogram after use of the balloon catheter.There was no avoidant treatment performed after the dissection.The procedure was completed and the patient survived.The physician did not know what caused the dissection.The patient was discharged without further incident on (b)(6) 2021.This report is being submitted to capture the turbo elite device and an acute occlusion was confirmed, after the device''s use, within the sfa.There was no alleged malfunction of the turbo elite device used 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
• MDR Report Key: 12096044
• Report Number: 1721279-2021-00119
• Device Sequence Number: 11949927
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)211126(10)FBC19L19A
• Combination Product (Y/N): Y
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2021

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: 11/26/2021
• Device Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: FBC19L19A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 90