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

Model Number VPR-GW-14

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

The guide wire was received at csi engaged in the oad driveshaft.Visual examination revealed that the spring tip was lodged within the driveshaft tip bushing section, and the spring tip was fractured.The distal fractured spring tip section was not returned.Scanning electron microscopy analysis of the fractured guide wire was performed and revealed torsional damage on the fracture faces, with rotational surface damage on the proximal spring tip coil.The distal fractured support ribbon exhibited fatigue striations.At the conclusion of the device analysis investigation, the report that the oad became stuck on the guide wire was confirmed.It was hypothesized that the spinning driveshaft made contact with the guide wire spring tip and although it is possible that the guide wire did not fully fracture at this point, this did contribute to the eventual fracture event.The diamondback peripheral orbital atherectomy device instructions for use 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.The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.An event involving the oad used in this procedure was submitted under mdr-3004742232-2020-00331.Csi id: 09235.

Event Description

The peripheral stealth orbital atherectomy device was operated for five treatment passes.The oad became stuck on the wire and both the wire and oad were removed.Once outside of the patient's body the guide wire fractured.

• 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: 10748353
• MDR Text Key: 213473465
• Report Number: 3004742232-2020-00337
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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: 10/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• 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