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

Model Number PRD-SC30-200

Device Problem Entrapment of Device (1212)

Patient Problem Vascular Dissection (3160)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

Angioplasty was performed via pedal access and contralateral approach in the superficial femoral artery (sfa) prior to insertion of a viperwire and stealth gen 2 peripheral orbital atherectomy device (oad).The oad stalled and became stuck in the vessel following a few treatments.Treatment was activated several times, and eventually the oad would no longer spin.Radial access was obtained, and angioplasty was performed near the area of the oad crown.The oad was then pulled, and it was freed from the vessel.A dissection was present in the area where the crown had become stuck.A stent was deployed to resolve the dissection.Imaging then showed a widely patent sfa with good runoff flow.The patient was well following the procedure.

Manufacturer Narrative

Device analysis conclusion: the device was received at csi for analysis.There were no damages or abnormalities identified that would have contributed to the reported events.When the device was powered on, all 3 speed leds remained lit.The device data log identified corruption, which prevented the device from operating.Electrical engineering was able to perform a factory reset after which the device functioned as intended.The device data log did confirm the reported stall event.The report that the device became stuck in the vessel and the report that a dissection occurred could not be confirmed through analysis.The report that the device stalled was confirmed through analysis, but the root cause of the stall could not 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: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 11693153
• MDR Text Key: 246242730
• Report Number: 3004742232-2021-00140
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)221031(10)347541
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 347541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 88