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

Model Number DBP-EX-200CLA145

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/01/2020

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 removal of the diamondback peripheral exchangeable orbital atherectomy device (oad) following a complex critical limb ischemia procedure, resistance was felt when the device entered the catheter to cross the aorta.The device was pulled, and the tip of the oad fractured.The handle of the oad was removed from the patient and the procedure was continued.When the wire was removed, the oad tip fragment dislodged in the right femoral artery.The fragment was secured to the vessel wall using a stent.The patient was in stable condition following the procedure.

Manufacturer Narrative

The reported oad was returned to csi for analysis.A visual examination confirmed that the driveshaft was fractured at the distal edge of the crown.Scanning electron microscopy was performed but due to secondary damage could not identify the fractography of the driveshaft fracture faces.It is hypothesized that the driveshaft underwent excessive tensile forces near the crown during removal from the vessel.The fractured filars were extending distally from the crown indicating that the filars were pulled to failure, however the exact root cause of the fracture is undetermined.At the conclusion of the device analysis investigation, the reported fracture was confirmed.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 prior to distribution.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 10749704
• MDR Text Key: 213502678
• Report Number: 3004742232-2020-00341
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491028
• UDI-Public: (01)10850000491028(17)220228(10)311256
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: DBP-EX-200CLA145
• Device Catalogue Number: 7-10031-11
• Device Lot Number: 311256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 68