MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.A final report will be submitted once the investigation is complete.Csi id: (b)(4).

Event Description

During treatment of a 90% stenosed severely calcified right coronary artery (rca) about 3.5 mm vessel diameter and severe degree of tortuosity, the driveshaft of a diamondback 360 orbital atherectomy device (oad) stretched and snapped proximal to the crown.Several treatments were completed at low speed and high speed in a distal to proximal direction.Difficulty removing the oad post treatment was observed, and it was confirmed that the oad had become separated.The separated fragment was successfully retrieved with a snare.The procedure was completed by using a drug eluting stent (des) that was successfully placed and deployed.

Manufacturer Narrative

The oad was returned for analysis.The driveshaft sections and guide wire were returned without the oad handle assembly.The driveshaft fracture was located 2.1cm from thedistal end of the driveshaft with the proximal section stretched.The fractured driveshaft sections were sent for scanning electron microscopy (sem) analysis.Sem analysis of the fractured filar faces showed evidence of fatigue and ductile torsion.Evidence of fatigue indicated that the damage occurred while spinning.It is hypothesized that an abnormal stress condition existed in the fracture area, such as unusual wear or from spinning in a tight bend.This is consistent with complaint details which stated that treatment was performed in a severely calcified artery with a severe degree of tortuosity.The exact root cause of the fracture remains unknown.The device history record for the reported oad could not be reviewed as the lot number was not provided.If the lot number is provided, a dhr review will be performed.Csi id: (b)(4).

Event Description

During treatment of a 90% stenosed severely calcified right coronary artery (rca) about 3.5 mm vessel diameter and severe degree of tortuosity, the driveshaft of a diamondback 360 coronary orbital atherectomy device (oad) stretched and snapped proximal to the crown.Several treatments were completed at low speed and high speed in a distal to proximal direction.Difficulty removing the oad post treatment was observed, and it was confirmed that the oad had become separated.The separated fragment was successfully retrieved with a snare.The procedure was completed by using a drug eluting stent (des) that was successfully placed and deployed.The patient was in stable condition with no complications.

Manufacturer Narrative

Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19045434
• MDR Text Key: 339435043
• Report Number: 3004742232-2024-00159
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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: DBEC-125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention