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

Model Number DBP-EX-150CLA145

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2021

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

Occluded lesions in the superficial femoral (sfa), posterior tibial (pt) and anterior tibial (at) arteries were crossed from an antegrade approach.The at was accessed via the pedal arch and a diamondback peripheral exchangeable orbital atherectomy device (oad) was used to treat the pt.Glideassist was used to navigate the oad around the pedal arch and treatment was performed in the at.When treatment with the oad was completed, glideassist was activated to remove the device, however it was stuck in the vessel.Multiple attempts were made to remove the device, but they were unsuccessful.Cut down surgery was performed to remove the device and the patient was stable following the procedure.

Manufacturer Narrative

The oad and guide wire were received at csi for analysis.There was no damage or abnormalities observed that would have contributed to the reported event.The oad crown was measured and found to be within specification.The driveshaft of the oad and the guide wire are separated and the distal guide wire spring tip section was not returned.Scanning electron microscopy analysis determined that the driveshaft was cut, and the wire was pulled to failure.This damage is likely due to handling and removal attempts during the procedure and is not considered a contributing factor to the reported event.Analysis of the device data log identified multiple stall events.It is possible that the stall events may have contributed to the reported event, however this was not confirmed.The root cause of the stall events is undetermined.At the conclusion of the device analysis investigation, the report that the device became stuck in the vessel could not be 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 EXCHANGEABLE 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: 11724969
• MDR Text Key: 247297049
• Report Number: 3004742232-2021-00156
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005909
• UDI-Public: (01)10852528005909(17)221231(10)358769
• 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: 04/29/2021

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: 12/31/2022
• Device Model Number: DBP-EX-150CLA145
• Device Catalogue Number: 7-10030-10
• Device Lot Number: 358769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR