MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMOND BACK 360 CLASSIC 2.0MM; CATHETER, CORONARY, ATHERECTOMY

Lot Number 447167-1

Device Problem Material Twisted/Bent (2981)

Patient Problem Laceration(s) (1946)

Event Date 02/23/2023

Event Type  Injury  

Event Description

Md was using product during procedure and wire became entangled inside of the patient.Patient required surgical intervention.

• Brand Name: DIAMOND BACK 360 CLASSIC 2.0MM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 16468434
• MDR Text Key: 310674395
• Report Number: MW5115378
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2023

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 Lot Number: 447167-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female