MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) STEALTH 360 ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number DBE-150

Device Problem Material Separation (1562)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

After three treatments of a non-tortuous, highly calcified, 90% stenosed lesion in the mid posterior tibia (pt) via contralateral femoral approach using stealth 360 peripheral orbital atherectomy device (oad), the radiopaque crown was observed to be not moving or spinning.Upon oad removal, the crown was found detached, but still on the driveshaft.Once all material was accounted for and confirmed retrieved, the treatment was completed with no further issues.The patient was stable.

Manufacturer Narrative

Return of the device is anticipated.A supplemental report will be submitted when the investigation is complete.Csi id: (b)(4).

Manufacturer Narrative

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.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.Csi id: (b)(4).

• Brand Name: STEALTH 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18357736
• MDR Text Key: 331187079
• Report Number: 3004742232-2023-00296
• Device Sequence Number: 1
• Product Code: MCW
• 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,Followup
• Report Date: 02/07/2024

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 Expiration Date: 11/30/2023
• Device Model Number: DBE-150
• Device Lot Number: 407853-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2021
• 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