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

Model Number PRD-SC30-MICRO

Device Problem Entrapment of Device (1212)

Patient Problem Perforation of Vessels (2135)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

The oad was received at csi for analysis.A visual analysis observed adhered biological material on the distal edge of the driveshaft crown.The morphology and root cause of the accumulation is unknown.The adhered biological material prevented a guide wire from passing through the device.The device data log was reviewed and revealed numerous stall conditions that confirm the report that the device stopped spinning.However, this could not be replicated during analysis.At the conclusion of the device analysis investigation, the report that the device stopped spinning and that tissue was present on the device were confirmed.The report that a perforation occurred could not be confirmed through analysis.There was no damage observed with the driveshaft or crown that would have contributed to the reported event.The driveshaft and crown were measured and found to meet specification.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 prior to distribution.(b)(4).

Event Description

A stealth peripheral orbital atherectomy device (oad) was used to perform a number of treatment passes until it stopped spinning and sounded as if it had become wrapped in tissue.The oad was removed from the patient and a small amount of tissue was present on the device.The oad was cleaned and reinserted, however it would not advance over the guide wire.Glideassist was used but did not resolve the issue.The oad was replaced to continue the procedure.Following balloon inflation, angiography was performed and a perforation was noted in the anterior tibial artery.The perforation was resolved with a covered stent and the patient was in stable condition.Per the opinion of the physician, the cause of the perforation is unknown, however the oad may have become caught in a dissection flap which contributed to the perforation.

• Brand Name: STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 10618906
• MDR Text Key: 209543712
• Report Number: 3004742232-2020-00297
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)220531(10)328106
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 328106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2020
• 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 Age: 65 YR