MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number GWC-12325LG-FLP

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 02/21/2024

Event Type  Injury  

Event Description

A diamondback 360 coronary orbital atherectomy device was used to treat a heavily calcified, 95% stenosed, 45-degree tortuous lesion from the left main (lm) coronary artery to the circumflex (cfx) artery via femoral approach.There was a previously placed stent in the distal cfx.Dilation with a 1.0mm sapphire otw balloon was attempted but it could not be advanced to the distal cfx.A viperwire advance coronary guide wire, floppy was placed thru the balloon.The physician believed they were in the true lumen when they exchanged the workhorse wire for the viperwire.The first treatment was performed antegrade in the cfx.After treatment, the viperwire jumped back possibly due to old stent strut.The next treatment was performed retrograde from cfx to the lm artery.When the physician attempted to remove the wire, the wire became stuck in the distal cfx.During removal attempts, the viperwire fractured.The fractured component was left in the cfx.A stent was placed proximal to the cfx.The lm artery did not have any issues noted, and balloons were able to be delivered.A heart pump was placed, and medication was administered to increase blood pressure.The patient was in stable condition with the heart pump and medication continuing to be administered to keep blood pressure elevated.On 24february2024, the abbott sales representative reported that the patient was stable in the hospital and receiving transfusion to increase their red blood cell (rbc) count.The heart pump has been removed and the patient was alert and talking with staff.

Manufacturer Narrative

The material inspection report for this guidewire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).

Manufacturer Narrative

Csi id: (b)(4).

Event Description

Additional information: the patient was discharged from the hospital on an unknown date.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18935160
• MDR Text Key: 338041027
• Report Number: 3004742232-2024-00136
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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 Lot Number: 8617952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male