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

Model Number	DBP-125SOLID145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned with the guide wire for analysis.The driveshaft was observed to be cut into three stretched out sections with the wire engaged in the distal section.The wire was observed to be cut near the tip bushing with the spring tip not returned for analysis.The damage was likely due to removal and troubleshooting attempts and were not considered a contributing factor to the event.Review of the device data log identified 12 stall events.The cause of the stall events were unable to be conclusively determined.The crown diameter was measured and met specification.When tested, the oad functioned 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).
Event or Problem Description
During the procedure, the diamondback 360 peripheral orbital atherectomy device (oad) got stuck sub intimal in a moderately calcified mid anterior tibial artery (at).The physician attempted to inflate a balloon to free the oad, however, this was unsuccessful.The oad sheath was cut, while keeping the viperwire advance guide wire in place to advance a guide catheter to incapsulate the oad and remove from the vessel.The oad was retrieved, with the crown remaining in the sheath.The procedure was completed after removal of the oad.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19004002
• Report Number: 3004742232-2024-00150
• Device Sequence Number: 8464712
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)241130(10)463532-1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2024

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: 11/30/2024
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 463532-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White