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

Model Number P-2ST-SO200-145

Device Problem Material Separation (1562)

Patient Problems Perforation of Vessels (2135); Foreign Body In Patient (2687)

Event Date 01/11/2023

Event Type  Injury  

Event Description

A stealth 360 peripheral orbital atherectomy device (oad) was used to treat a 70-80% stenosed right femoral artery.Two treatments on low speed, two treatments on medium speed, and one treatment on high speed were performed.During the last treatment, the oad stopped spinning and the tip of the driveshaft was fractured.While removing the oad and viperwire advance guide wire, it was observed that the tip of the guide wire was in vivo.Angiographic imaging was performed and revealed a perforation of the femoral vessel.Balloon angioplasty and stent placement were performed to resolve the perforation.A stent was placed to entrap the fractured driveshaft and guide wire in vivo.The patient was stable.

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.; 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: 16254358
• MDR Text Key: 308269160
• Report Number: 3004742232-2023-00022
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491479
• UDI-Public: (01)10850000491479(17)240228(10)419972-1
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: P-2ST-SO200-145
• Device Catalogue Number: 7-10059-13
• Device Lot Number: 419972-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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 Outcome(s): Required Intervention