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

Model Number RAD-SC30-175

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/14/2022

Event Type  Injury  

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).

Event Description

Pedal access was gained followed by right femoral access.A wire was used to cross the chronic total occlusion (cto) in the proximal to the 5mm - 6mm mid popliteal artery.Wire exchange was performed.Via the right groin, the stealth 360 peripheral orbital atherectomy device (oad) was advanced proximal to the cto.One treatment was performed on low speed, followed by a treatment on medium speed.A treatment was performed on high speed at which point the oad became stuck.The physician pulled on the oad several times, the last time with additional force.The driveshaft and sheath appeared to have fractured; however, the sheath had not separated while in vivo.Via pedal access, a snare was used to retrieve the driveshaft fragment.The oad was removed.A jade balloon was placed, and two low pressure inflations were performed for a minute each time to complete the procedure.The patient experienced no consequences as a result of this event.

• 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 16018282
• MDR Text Key: 305872929
• Report Number: 3004742232-2022-00318
• 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
• Report Date: 12/20/2022

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 Model Number: RAD-SC30-175
• Device Catalogue Number: 7-10059-07
• Device Lot Number: 458741-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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
• Patient Sex: Male