MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number DBEC-125

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/12/2018

Event Type  malfunction  

Event Description

Brief factual description: (b)(6) patient was undergoing a coronary intervention in the cath lab.The distal tip of the orbital atherectomy catheter, called the nose cone, detached from the body of the catheter while in the right coronary artery (rca).After balloon dilation of the rca to alter the geometry of the vessel, the broken tip was retrieved on the wire that it was delivered over.All pieces of the fractured catheter were removed successfully, no foreign body remained in the patient.A stent was placed successfully in the proximal rca after removal of the atherectomy catheter.The patient had transient hemodynamic instability.Manufacturer response for diamondback 360 coronary atherectomy system, diamondback 360® coronary orbital atherectomy system (per site reporter).The company representative was on-site and likely received the device.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC; csi headquarters; 1225 old highway 8 nw; st paul MN 55112
• MDR Report Key: 7999049
• MDR Text Key: 124958417
• Report Number: 7999049
• 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: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 234090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA