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

Model Number DBEC-125

Device Problems Unintended System Motion (1430); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

The reported oad was received for analysis.A visual examination confirmed that the driveshaft was fractured on the distal side of the crown weld.Scanning electron microscopy was performed and identified evidence of fatigue striations on the fractured faces of the driveshaft filars.Information was provided to csi that the patient anatomy was tortuous, which may indicate that the device was operated around a tight bend or into a tight bend shape, however the root cause of the fractured driveshaft could not be confirmed.At the conclusion of the device analysis investigation, the reported driveshaft fracture was confirmed.The reported crown jumping was unable to be confirmed through analysis.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).

Event Description

During a coronary atherectomy procedure using a csi orbital atherectomy device (oad), the tip of the device became detached.The target lesion was located in the right coronary artery (rca) and was 60% stenosed.During the first pass with the oad, the device was noted to jump through the lesion.The patient began to require hemodynamic support.Two additional passes were performed with the oad.When the device was removed from the patient, it was noted that the tip of the oad had become detached and remained in the patient.Balloon angioplasty was performed to release the device fragment from the calcium, and the fragment was removed along with the guide wire.Additional balloon angioplasty and stent placement were performed, however the procedure was aborted due to the patient status.Following the procedure, the patient was in stable condition.

Event Description

Additional event information was received indicating that the detached device fragment occluded the vessel prior to removal.

• 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; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7949137
• MDR Text Key: 123193500
• Report Number: 3004742232-2018-00302
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)200731(10)234090
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 234090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• 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
• Patient Age: 78 YR
• Patient Weight: 79