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

Model Number DBEC-125

Device Problem Material Separation (1562)

Patient Problems Angina (1710); Foreign Body In Patient (2687)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

The oad was received at csi for analysis.Visual examination revealed the driveshaft was fractured at the proximal edge of the crown.The distal driveshaft fragment was not returned.Scanning electron microscopy analysis revealed that two of the fractured filar faces exhibited possible fatigue striations and rotational damage.The third fractured filar exhibited extensive secondary surface damage.When tested, the oad functioned as intended.At the conclusion of the device investigation analysis, the report that the oad fractured was confirmed.Driveshaft flexing at the weld location can initiate a fatigue fracture.It was hypothesized that the driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance, which pushed the driveshaft into a tight bend shape, however the exact root cause of the fracture event could not be confirmed.The diamondback coronary orbital atherectomy system instructions for use states the following warning, "never force the crown if any resistance is felt within the vessel as vessel perforation may occur.If resistance is felt, retract the crown, while monitoring the cause of the resistance, and immediately stop treatment.Use fluoroscopy to analyze the situation and to monitor the cause of the resistance." 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.Additional patient information has been requested, but has not yet been received.If additional information is received a supplemental report will be submitted.Csi id: (b)(4).

Event Description

After multiple unsuccessful attempts to cross a lesion in the left circumflex artery via antegrade, the diamondback coronary orbital atherectomy device (oad) stalled and the driveshaft tip fractured.The vessel was tight with moderate to severe tortuosity.Attempts to retrieve the fragment were unsuccessful and the fragment remained in vivo.The patient was discharged in stable condition, but with persistent angina.As of 29-oct-2020 plans for a follow-up procedure to remove the fragment are under review.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 10766064
• MDR Text Key: 214090790
• Report Number: 3004742232-2020-00344
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220531(10)327105
• 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
• Report Date: 10/30/2020

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: 05/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 327105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2020
• 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): Other