MAUDE Adverse Event Report: CSI PRODUCTS (CARDIOVASCULAR SYSTEMS) INCORPORATED C. S. I. DIAMOND BACK CORONARY CLASSIC; CATHETER, CORONARY ATHERECTOMY

Catalog Number PART# 381624

Device Problems Break (1069); Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2019

Event Type  Injury  

Event Description

Complex pci of the rca using atherectomy, csi performed for a single run.Device advanced then got stuck on the wire, shearing it.Multiple attempts to retrieve wire failed.Distal end of wire retained in distal rca.Pt admitted and underwent cabg.

• Brand Name: C. S. I. DIAMOND BACK CORONARY CLASSIC
• Type of Device: CATHETER, CORONARY ATHERECTOMY
• Manufacturer (Section D): CSI PRODUCTS (CARDIOVASCULAR SYSTEMS) INCORPORATED; 1255 old highway 8nw; st. paul MN 55112
• MDR Report Key: 8582466
• MDR Text Key: 144255422
• Report Number: MW5086383
• 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: 04/26/2019

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 Catalogue Number: PART# 381624
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR