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

Model Number	DBEC-125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is anticipated but has not yet begun.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
An atherectomy procedure was performed in the right coronary artery (rca) with a diamondback coronary orbital atherectomy device (oad).Reportedly, the rca was extremely tortuous and guide wire advancement to the target lesion was difficult.Additional force was used to advance the device into to the lesion.On imaging, the oad appeared to bend distal to the crown, but the procedure was continued regardless of the bend.Six treatments were administered with the oad.When the device was withdrawn a short distance, imaging showed that the tip of the oad had detached.The tip was retrieved via advancement of the guideliner and slow retraction of the guide wire.The procedure was completed without further issue.An angiogram was performed to verify that the patient had experienced no adverse events, and the patient was discharged the following day.
Additional Manufacturer Narrative
The device was returned to csi for analysis with a driveshaft fracture on the distal side of the crown weld.Scanning electron microscope (sem) analysis identified evidence of fatigue striations on the fractured faces of the driveshaft filars.The exact cause of the fractured driveshaft could not be confirmed.The crown was not returned with the oad.Additional follow-up was performed to determine whether the crown could have been left in situ, and field staff stated that extensive imaging was done post-procedure.Sem analysis identified corrosion along the crown weld location.It is possible that exposure to saline for an extended period of time after the procedure allowed corrosion formation in the crown weld and resulted in crown material separation from the driveshaft and weld.However, the exact cause of the crown detachment is unknown.At the conclusion of the failure analysis investigation the reported event was confirmed.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.(b)(4).

• Brand Name: DIAMONDBACK 360 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: 7828672
• Report Number: 3004742232-2018-00269
• Device Sequence Number: 1287053
• Product Code: MCX
• UDI-Device Identifier: 10852528005169
• UDI-Public: (01)10852528005169(17)190430(10)190232
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-02
• Device Lot Number: 190232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1