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

Model Number VPR-GW-FLEX14

Device Problem Material Separation (1562)

Patient Problems Intraoperative Pain (2662); Foreign Body In Patient (2687)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

The reported guide wire was received at csi for analysis.Visual examination confirmed that the guide wire was fractured.Scanning electron microscopy analysis identified evidence of heavy rotational grinding at the proximal fracture site.At the conclusion of the device analysis investigation, the report that the guide wire fractured was confirmed.It was hypothesized that the guide wire fractured due to excessive wear and possible fatigue from spinning under axial compression and/or in a tight bend, and a close distance between the driveshaft and guide wire, however this was not confirmed and the root cause of the fracture was unknown.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.Csi id: (b)(4).

Event Description

Orbital atherectomy treatment was selected for the superficial femoral artery, and during the sixth treatment pass the patient complained of foot pain.Imaging was performed to the location of the distal wire and revealed that the wire had migrated down the tibial vessels.The wire was pulled back; however it would not move and both the peripheral orbital atherectomy device and wire were removed from the patient's body.Upon removal the middle of the wire was found to have fractured and the fragment was retrieved with the use of a snare device.Following the procedure the patient was alert and pain free.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 11655041
• MDR Text Key: 245076737
• Report Number: 3004742232-2021-00127
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005718
• UDI-Public: (01)10852528005718(17)221130(10)354845-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 354845-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• 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
• Patient Age: 66 YR
• Patient Weight: 68