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

Model Number VPR-GW-14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

The viperwire guide wire was received at csi for analysis not engaged with the oad.Visual examination confirmed the reported fracture.There was no damage to the spring tip.Scanning electron microscope (sem) analysis revealed evidence of fatigue and rotational wear on the surface of the wire near the fracture site.It is hypothesized that the excessive wear led to the eventual fracture of the guide wire, although the exact root cause of fracture remains undetermined.The material inspection report for the wire could not be reviewed as the lot number was not provided.If the lot number is provided, an mir review will be performed.Csi id: (b)(4).The oad fracture will be submitted in mdr 3004742232-2022-00099.

Event Description

A viperwire guidewire and orbital atherectomy device (oad) were used for treatment of a lesion in the peroneal artery.The 3.5mm vessel was 90% stenosed, with calcification.The oad buckled near the distal end of the crown after one-to-one motion was lost.Imaging indicated the nose of the oad had separated from the crown.Further imaging confirmed the nose of the oad and a portion of the viperwire had fractured.The oad and wire were removed from the patient.Attempts to retrieve the oad nose and wire fragment were made.The nose of the oad was covered with placement of a covered stent peroneal access was obtained, and the physician was able to snare the wire fragment and remove it from the patient.The patient remained in stable condition throughout the procedure.However, the patient's lower extremity had become swollen, and high pressures were noted.The patient required a fasciotomy.Following the fasciotomy, the patient was stable and awaiting discharge.In the opinion of the physician, the specific cause of the adverse event was device entrapment and prolonged sheath placement.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 14189609
• MDR Text Key: 289907497
• Report Number: 3004742232-2022-00100
• Device Sequence Number: 1
• Product Code: MCW
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White