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

Model Number	DBEC-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device history record for this oad 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.It is possible the site may release the device to csi for analysis following its own internal investigation.If the device is returned, a supplemental report will be sent with analysis findings from csi.Csi id: 09087.
Event or Problem Description
A diamondback coronary orbital atherectomy device was selected for treatment of lesions in the mid and proximal segments of the right coronary artery (rca).The vessel was tortuous, and difficulty was encountered during placement of the guide catheter.Multiple guide catheters were inserted in an attempt to obtain adequate support.Once a guide catheter was successfully placed, the vessel was primary wired with a viperwire guide wire.Glideassist was activated to advance the crown past the tortuous portion of the proximal rca in order to treat the distal lesion first.Several atherectomy treatments were administered in the mid rca on low speed for 25 to 30 seconds each.The oad was pulled back in order to treat the proximal lesion.During distal to proximal treatment, the guide catheter was inadvertently pulled farther into the vessel, and the oad was pulled into the guide catheter.The oad stalled.The driveshaft had also fractured on the proximal side of the crown.The guide catheter was used to retrieve the fragment, and everything was removed from the patient.Another guide catheter was placed, and three stents were deployed.The patient tolerated the procedure well.
Additional Manufacturer Narrative
Device analysis conclusion: the oad and wire were received at csi for analysis.The wire was engaged in the oad.Visual examination confirmed fracture of the driveshaft on the proximal side of the crown.The fractured distal driveshaft section was returned engaged on the guidewire.Driveshaft flexing at the weld location can initiate a fatigue failure, and scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.At the conclusion of the device analysis investigation, the reported fracture was confirmed.It is hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.However, the exact root cause of this reported complaint remains undetermined.The device history record for this oad 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 10676964
• Report Number: 3004742232-2020-00312
• Device Sequence Number: 11565298
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)211130(10)300450
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 300450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 66