MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number DBEC-125

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/19/2022

Event Type  Injury  

Event Description

A 1.25mm x 135 cm diamondback 360 coronary orbital atherectomy system was initialized per manufacturer recommendation.The atherectomy system was presumed to have fractured the distal viperwire, dissociated the distal end of the wire from the main body of the wire and embolizing to distal vessel.Fragment was not able to be retrieved via snare devices and in turn, resulted in a stent to be deployed to adhere the fragment to the arterial wall to prevent flow disruption.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 15843132
• MDR Text Key: 304119667
• Report Number: 15843132
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2022,08/22/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2022
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 70 KG