MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number VPR-GW-17

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

Patient Problem Vascular Dissection (3160)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive sincethe reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.(b)(4).

Event Description

A peripheral orbital atherectomy procedure was planned.The target lesion was an 85% stenosed, moderately to severely calcified lesion that was located in the tibioperoneal trunk.The lesion was 100mm in length and located in a 4mm diameter section of the artery.The lesion was wired with a non-csi guide wire, but access was lost.After rewiring the lesion with a viperwire guide wire, a type c dissection was noted.A decision was made to not continue with orbital atherectomy, and percutaneous transluminal angioplasty (pta) was performed to resolve the dissection.The procedure was completed with pta and a stent.The patient's status was good following the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 8557754
• MDR Text Key: 143377299
• Report Number: 3004742232-2019-00111
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005084
• UDI-Public: (01)10852528005084(17)200831(10)241348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: VPR-GW-17
• Device Catalogue Number: 72023-02
• Device Lot Number: 241348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention