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

Model Number	420-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.(b)(4).
Event or Problem Description
It was reported to philips (b)(6) on (b)(6) 2021 that a peripheral atherectomy procedure commenced on (b)(6) 2021 to treat a slightly calcified in stent occlusion of the patient''s superficial femoral artery (sfa).This event was reported as part of a postmarket study in (b)(6).The physician chose a spectranetics turbo elite laser atherectomy catheter to treat the lesion, proximal to distal.According to the report, after the turbo elite device was used, an arterial non flow limiting dissection (grade c) was confirmed, outside of and proximal to the stent.A plain old balloon angioplasty (poba) was performed, but dissection was confirmed after poba as well.Afterward, it was reported "no particular bailout was performed".The procedure was completed, and the patient was discharged from the hospital on (b)(6) 2021 with no adverse event being reported.There was no alleged malfunction of the turbo elite device used in the procedure.
Additional Manufacturer Narrative
H3): the device was discarded, thus no investigation could be completed.H6): added codes: 4755, 4619, and 4621.

• 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: 11826323
• Report Number: 1721279-2021-00090
• Device Sequence Number: 19716617
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)211223(10)FBA19M19B
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K170059
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 12/23/2021
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA19M19B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014 JUPITAR 10 (BSJ) GUIDE WIRE; 0.014 VASSALLO NS3 CORDIS GUIDE WIRE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; TERUMO DESTINATION 6F INTRODUCER SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 41