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

Model Number DBEC-125

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 12/02/2020

Event Type  Injury  

Manufacturer Narrative

Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.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.The event for the guide wire used in this procedure was reported under mdr 3004742232-2020-00423.Csi id: 09463.

Event Description

Orbital atherectomy was administered for three treatment passes in a distal-to-proximal direction on low speed in the left circumflex artery.Attempts to remove the orbital atherectomy device were made by pulling the device while glideassist mode was active, but the crown became stuck in the vessel.The oad was pulled hard, which resulted in the device moving to the distal site and becoming stuck again.A second wire and balloon were inserted in an attempt to widen the lesion, however the oad remained stuck.The oad handle was cut and a guide catheter was inserted over the oad.The oad was pulled back to the cx ostium, where it became stuck again.A snare was inserted, however the snare, oad driveshaft and the guide wire fractured.The patient was transferred to the hospital and an additional snare device was inserted in an attempt to retrieve the fragments, however it was also unsuccessful.A surgical procedure was performed and all components were removed from the patient.The patient was in good condition following the procedure.

Manufacturer Narrative

The reported oad was received at csi for analysis, engaged on the guide wire.Visual examination revealed that the distal end of the driveshaft fracture was severely elongated and that the driveshaft crown was not returned.Scanning electron microscopy analysis identified evidence of ductile torsion, which suggested a tensile issue had occurred.This was consistent with the reported event, which detailed the oad was pulled hard multiple times.At the conclusion of the device analysis investigation, the report that the oad fractured and the crown became stuck in the vessel was confirmed, however the exact root cause could not be 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.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; saint paul MN 55112
• MDR Report Key: 11076552
• MDR Text Key: 223730587
• Report Number: 3004742232-2020-00422
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005794
• UDI-Public: (01)10852528005794(17)220430(10)322404
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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: 04/30/2022
• Device Model Number: DBEC-125
• Device Lot Number: 322404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR