MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 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 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

During the first treatment with a diamondback pluto coronary orbital atherectomy device (oad) in the left circumflex artery (lcx), the crown became stuck in the vessel.Glideassist was activated, but the oad remained stuck in the vessel.The guide wire was pulled back through the device during the attempts to free the oad.The oad was then pulled, and the driveshaft fractured on the proximal side of the crown.Several unsuccessful attempts to snare the fragment were made.Eventually, a wire was advanced in the subintimal plane, and serial balloon inflations were performed to open a channel, thereby causing a dissection.Stents were deployed to entrap the fragment against the vessel wall.Post procedure imaging showed the vessel was open with brisk flow.The patient was admitted to the icu for recovery.

Manufacturer Narrative

Device analysis conclusion: the device was received at csi for analysis.Visual examination showed that the driveshaft filars were deformed, and a fracture was present.A distal portion of the driveshaft was not returned, which is consistent with details reported to csi.Scanning electron microscopy analysis of the driveshaft fracture showed evidence of torsion and stretching.It is hypothesized that the driveshaft fractured due to tensile forces that occurred during removal attempts by the physician.This is also consistent with details reported to csi.The reported fracture was confirmed through analysis, though the exact root cause of the fracture could not be determined.The cause of the device reportedly becoming stuck could not be determined through analysis.The reported dissection also could not be confirmed through analysis.The device history record for this device lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event, and the device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 11087463
• MDR Text Key: 224081310
• Report Number: 3004742232-2020-00425
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220930(10)345420-1
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: 09/30/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 345420-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 79