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

Model Number	DBEC-125
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The intended procedure was left heart catheterization with percutaneous coronary intervention on a patient.The diamondback 360 coronary orbital atherectomy device (oad) was used in the right coronary artery and circumflex artery.Upon removal of oad, it was observed that the tip of the oad proximal to burr was broken off.The fragment was retrieved on the guide wire.Breakage was noted after atherectomy was complete and after vessel preparation was finished.Medwatch report number: (b)(4).
Additional Manufacturer Narrative
The investigation is ongoing.A final report will be submitted once the investigation is complete.Medwatch report number: (b)(4).Csi id: (b)(4).
Additional Manufacturer Narrative
The diamondback 360 coronary orbital atherectomy device (oad) was returned with the coronary guide wire engaged in the fractured distal section.The returned 0.012" wire could not pass the shipping damage.After removal of the damage, the returned wire was able to pass the remaining driveshaft and handle assembly without issue.The fractured driveshaft sections were sent for scanning electron microscopic (sem) analysis.Driveshaft flexing at the weld location can initiate a fatigue failure, and sem analysis identified possible fatigue striations at the site of the driveshaft fracture.It was hypothesized that this driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape, although the exact root cause of this reported complaint is undetermined.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)(6).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old highway 8 nw; st. paul 55112
• MDR Report Key: 18978009
• Report Number: 3004742232-2024-00140
• Device Sequence Number: 6638997
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250831(10)504272-1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 08/31/2025
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 504272-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White