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

Model Number DBP-150CLASS145

Device Problem Material Separation (1562)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

A diamondback 360 peripheral orbital atherectomy device was used to treat the anterior tibial artery.Fluoroscopy imaging was performed during a treatment and it was observed that the crown was not moving with the tip of the driveshaft.The oad was removed, and the crown was observed to be moving up and down the shaft.A new oad was used to complete the procedure.The patient was stable.

Manufacturer Narrative

The oad was returned to csi without the guidewire.Analysis revealed the crown to be detached and located proximal to its original location on the driveshaft.Scanning electron microscopy analysis of the crown identification and driveshaft crown bond section revealed the presence of adequate solder residue indicating a sufficient crown bond present prior to the separation.Diagnostic analysis identified treatment runs averaging forty-five seconds.The instructions for use states: "a rest period of thirty seconds is recommended for every thirty seconds of treatment, with a maximum treatment of eight minutes per oad." the root cause of the crown detachment was unable to be determined.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).

• 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16743671
• MDR Text Key: 313331739
• Report Number: 3004742232-2023-00105
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491240
• UDI-Public: (01)10850000491240(17)240630(10)437270-1
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: 7-10057-08
• Device Lot Number: 437270-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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 Sex: Male
• Patient Race: Black Or African American