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

Model Number GWC-12325LG-FLP

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Embolism (1829)

Event Date 06/05/2019

Event Type  Injury  

Event Description

During coronary intervention / arthrectomy of right coronary artery the rotablator burr became lodged in the artery and could not be advanced forward or backwards.It was then discovered that the burr actually broke off the device and remained lodged in the artery.For fear of further injury to the artery, the physician discontinue retrieval attempts and decided to use a guideliner catheter to retrieved the lodged burr.Unfortunately, then the tip of the guideliner catheter broke off in the vessel and eventually ended up in the ascending aorta.Surgical back up was called and the cardiovascular surgeon took the patient to the operating room for a right coronary artery bypass for removal of the retained foreign objects.The catheter tip was successfully removed but the rotablator burr was not able to be retrieved.Remarkable, the patient remained stable throughout the entire time.Following surgery the patient was admitted to critical care and is stable at this point.Manufacturer response for catheter, guideliner (per site reporter).Hospital is in process of notifying the manufacturer.Manufacturer response for diamondback 360 coronary classic, diamondback 360 coronary orbital atherectomy system (per site reporter).The were going to fill out a report and was interested in obtaining the device.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul MN 55112
• MDR Report Key: 8711827
• MDR Text Key: 148443033
• Report Number: 8711827
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2019

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 Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 268460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 25915 DA