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

Model Number DBP-200MAX145

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

The oad was returned to csi with a fracture at the distal side of the crown.The fractured distal section was not returned for analysis.Scanning electron microscopy (sem) analysis of the fractured filars shows evidence of fatigue.This is an indication that the driveshaft was spun in a high stress environment.However, the exact root cause of the fracture was unable to be conclusively determined.The peripheral orbital atherectomy system indications for use cautions: "when treating tight stenosis, create a channel at low or medium speed before traversing the lesion at high speed.Crossing a tight stenosis on high speed may cause the shaft and/or guide wire to fracture as a result of excessive force." 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 Description

The diamondback 360 peripheral orbital atherectomy device (oad) was used to perform one low speed treatment and two high speed treatments.During the third treatment, it was noticed the driveshaft tip was not coming back with the crown.The oad was removed, and it was noted the tip had detached from the oad.The fractured tip was retrieved via wire pull back.Balloon angioplasty was performed, and a stent was placed to complete the procedure.The patient was in stable condition.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul
• 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: 16638170
• MDR Text Key: 312251506
• Report Number: 3004742232-2023-00082
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850026568445
• UDI-Public: (01)10850026568445(17)241031(10)457739-1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-200MAX145
• Device Catalogue Number: 7-10057-10
• Device Lot Number: 457739-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• 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 Age: 69 YR
• Patient Sex: Male