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

Model Number 420-006

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.(b)(4).

Event 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.

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
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11826323
• MDR Text Key: 265548097
• Report Number: 1721279-2021-00090
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)211223(10)FBA19M19B
• Combination Product (y/n): Y
• PMA/PMN Number: K170059
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 06/06/2021
• Supplement Dates FDA Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 41