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

Model Number VPR-GW-14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

The diamondback gen2 peripheral orbital atherectomy device (oad) was advanced for treatment to a heavily calcified tibial artery and stalled.The oad was moved backwards to restart treatment, however the oad stopped spinning once it connected with the calcified segment.During the removal process the oad could not be removed and the guide wire was removed along with the oad.The oad could not be removed from the guide wire once outside the patient's body.The procedure was completed with balloon angioplasty.There were no patient complications.Failure analysis identified a fractured guide wire spring tip within the driveshaft.

Manufacturer Narrative

The reported oad was received at csi for analysis, engaged on the guide wire.A visual examination revealed a kink in the guide wire that corresponded with a driveshaft kink, and the spring tip proximal solder bond was damaged.Embedded spring tip material within the tip bushing prevented removal of the guide wire.The material within the driveshaft was consistent in dimension with the guide wire spring tip coil.Both showed evidence of rotational damage consistent with the oad spinning over the spring tip.Scanning electron analysis revealed further evidence that the spring coil had been spun over.At the conclusion of the device analysis investigation, the report that the oad was stuck on the guide wire and the oad stopped spinning was confirmed.The root cause was determined to be the guide wire fracture.The root cause of the fracture was considered to be use not consistent with the instructions for use (ifu) by contacting the spring tip with the spinning driveshaft.The diamondback gen2 peripheral orbital atherectomy system ifu warns: when moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip and the distal end of the shaft (10 cm minimum).If the distance between the shaft tip and the guide wire spring tip is insufficient, the shaft tip may damage the guide wire spring tip and result in dislodgement of the guide wire spring tip.Use contrast injections and fluoroscopy to monitor movement of the shaft tip in relation to the guide wire spring tip.Csi id: (b)(4).

• 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: 13367643
• MDR Text Key: 289779476
• Report Number: 3004742232-2022-00014
• 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: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/27/2022
• 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 Age: 86 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic