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

Model Number DBP-125SOLID200

Device Problem Positioning Problem (3009)

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

Event Date 03/06/2023

Event Type  Injury  

Manufacturer Narrative

The oad was returned to csi for analysis.There were no abnormalities or damage identified with the driveshaft or crown that would have contributed to the event.There was overloading identified on the driveshaft at the lap weld and extending 1 centimeter distally.This damage prevented a test wire from passing through the device.It was unknown if the overloaded driveshaft was related to the reported event.Review of the device data log did not identify any stall events during the procedure.The root cause of the overloaded driveshaft is unable to be conclusively determined.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 Description

During the orbital atherectomy procedure, the stealth 360 orbital atherectomy device (oad) prolapsed near the patient's heart when it was introduced.The physician re-obtained access via the patient's other arm rather than via pedal access.A new oad with greater length was used and the same event occurred.Under fluoroscopy, it was observed the oad was not advancing.The physician observed the oad prolapsed in the heart once again.Balloon angioplasty was used 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 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: 16656799
• MDR Text Key: 312443913
• Report Number: 3004742232-2023-00090
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491219
• UDI-Public: (01)10850000491219(17)230430(10)379387-1
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: DBP-125SOLID200
• Device Catalogue Number: 7-10057-05
• Device Lot Number: 379387-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2021
• 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: 67 YR
• Patient Sex: Male