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

Model Number DBP-125MICRO145

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

The equipment was prepped per device standards.The device was put into place, locked on the wire, and the atherectomy crown was activated.Upon initiation of rotational atherectomy in the pull back phase, the device arrested on the wire and was unable to be removed.A second vascular surgeon was called in to trouble shoot.The team was successful in retrieving the device from the patient's vessel with an advanced technique.A proximal ata dissection was noted and resolved with prolonged inflation of 3mm balloon.Subsequently, there was in-line ata blood flow to the foot.

• Brand Name: DIAMONDBACK PERIPHERAL
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 19040597
• MDR Text Key: 339365783
• Report Number: 19040597
• Device Sequence Number: 1
• Product Code: MCW
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male