MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) 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 03/22/2024

Event Type  Injury  

Event Description

The diamondback 360 coronary orbital atherectomy device (oad) was used for distal-to-proximal treatment of a moderately calcified, moderately tortuous, 90% stenosed de novo lesion in the proximal circumflex artery (cx) via radial approach.The reference vessel diameter was 4.0mm and the lesion diameter was 1.3mm.During wiring, there was difficulty in advancing into the nodule in the minimum luminal area (mla).Intravascular ultrasound (ivus) was used to check the lesion.Following four low-speed treatments, a fifth treatment was performed.Cineangiography revealed that the oad driveshaft has fractured.The oad was removed, and the fractured component was retrieved with a non-csi guide wire.In the opinion of the physician, the driveshaft possibly fractured due to getting stuck in the nodule segment.Ivus confirmed there was no further complication to the patient.The procedure was completed with non-csi atherectomy and drug-coated balloon angioplasty.The patient was stable.

Manufacturer Narrative

Return of the device is anticipated.A supplemental report will be submitted when the investigation is complete.Csi id: (b)(4).

Manufacturer Narrative

The oad was returned with the viperwire engaged in the distal fractured oad driveshaft section.The driveshaft fracture is located at the proximal side of the crown.Scanning electron microscopy analysis identified fatigue striations at the site of the driveshaft fracture.It is hypothesized that the driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.However, the exact root cause of the driveshaft fracturing could not be conclusively determined.When tested, the oad spun as intended.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. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19145317
• MDR Text Key: 340617481
• Report Number: 3004742232-2024-00173
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Lot Number: 438255-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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 Sex: Female