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

Model Number	PRD-SC30-MICRO
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was received at csi, engaged on the viperwire guide wire.A visual examination revealed that the driveshaft crown was lodged within the distal end of the saline sheath, both of which were damaged, deformed and stretched distally.There were multiple areas of axial compression damage along the saline sheath.The guide wire was removed with resistance due to the damaged driveshaft.When tested, the oad functioned as intended.Review of the device data log identified stall events during the procedure.The cause of the stall events was unknown.At the conclusion of the device investigation analysis, the report that the oad became stuck in the vessel and stuck on the guide wire could not be confirmed.There was no damage or abnormalities with the driveshaft or crown that would have contributed to the device becoming stuck in the vessel and due to the returned condition of the driveshaft the device stuck on wire event could not be confirmed.The stall event was confirmed on the device data log and may have been related to the device becoming stuck, however this could not be confirmed.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.(b)(4).
Event or Problem Description
The diamondback peripheral orbital atherectomy device (oad) spun through the lesion, and when retracted backwards through the lesion the device powered off completely due to excessive torque.The crown was stuck in the lesion.Glideassist and low speed were attempted, however the oad powered off again.A balloon was placed next to the crown and inflated.Once deflated, the oad was pulled to free the crown and likely caused the driveshaft to become stretched, resulting in the guide wire becoming stuck in the oad during removal.The procedure was completed with balloon angioplasty.There were no patient adverse events and the patient was discharged as planned.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 12866550
• Report Number: 3004742232-2021-00386
• Device Sequence Number: 6024957
• Product Code: MCW
• UDI-Device Identifier: 10850000491264
• UDI-Public: (01)10850000491264(17)221231(10)357913-1
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: PRD-SC30-MICRO
• Device Catalogue Number: 7-10059-01
• Device Lot Number: 357913-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: Black Or African American