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

Model Number	414-151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	12/15/2020
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 a philips (b)(4) representative on (b)(6) 2021 that on (b)(6) 2020, a peripheral vascular procedure was performed to treat in-stent restenosis (isr) in the patient's distal superficial femoral artery (sfa).This procedure was part of a (b)(4)postmarket study.Two spectranetics turbo elite laser atherectomy catheters were used during the procedure (models 417-152 and 414-151) to treat the patient and after the turbo elite device (model 414-151) was used, an embolization was confirmed by angiogram.Plain old balloon angioplasty (poba) was then performed, and a repeat angiogram confirmed no further embolization.The procedure was completed and the patient survived.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
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: 11631217
• Report Number: 1721279-2021-00054
• Device Sequence Number: 3898983
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)220102(10)FAY19M10A
• 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): 03/09/2021

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: 01/02/2022
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY19M10A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TURBO ELITE MODEL 417-152
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 64