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

Model Number	PRD-SC30-200
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The stealth peripheral orbital atherectomy device was operated for three treatment passes and became stuck on the guide wire.The oad and wire were removed and a pinhole was observed on the outside of the sheath.The procedure was completed with percutaneous transluminal angioplasty.
Additional Manufacturer Narrative
The reported oad and guide wire were received at csi for analysis.Visual examination identified a driveshaft filar protruding from the saline sheath.There were no missing filar fragments.Holes were also observed along the saline sheath, likely from the damaged driveshaft spinning within the sheath.There was no damage observed with the oad handle or guide wire.The wire was removed with resistance from the oad.Scanning electron microscopy analysis of the fractured filar faces identified evidence of fatigue.At the conclusion of the device analysis, the report that the device was stuck on the wire and the driveshaft was damaged was confirmed.It was hypothesized that a compressive force was applied on the sheath while spinning, which caused an elevated stress environment resulting in the eventual driveshaft damage, however this was not confirmed and the root cause of the damage remains unknown.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).
Additional Manufacturer Narrative
The reported oad and guide wire were received at csi for analysis.Visual examination identified a driveshaft filar protruding from the saline sheath.There were no missing filar fragments.Holes were also observed along the saline sheath, likely from the damaged driveshaft spinning within the sheath.There was no damage observed with the oad handle or guide wire.The wire was removed with resistance from the oad.Scanning electron microscopy analysis of the fractured filar faces identified evidence of fatigue.At the conclusion of the device analysis, the report that the device was stuck on the wire and the driveshaft was damaged was confirmed.It was hypothesized that a compressive force was applied on the sheath while spinning, which caused an elevated stress environment resulting in the eventual driveshaft damage, however this was not confirmed and the root cause of the damage remains unknown.Follow up attempts for the physician opinion regarding the blood backing up were made, but could not be obtained.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).
Event or Problem Description
The stealth peripheral orbital atherectomy device was operated for three treatment passes and became stuck on the guide wire.The oad and wire were removed and a pinhole was observed on the outside of the sheath.Blood was also observed within the driveshaft, near the pinhole.The procedure was completed with percutaneous transluminal angioplasty.

• Brand Name: STEALTH ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• 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: 12708094
• Report Number: 3004742232-2021-00360
• Device Sequence Number: 1467299
• Product Code: MCW
• UDI-Device Identifier: 10852528005053
• UDI-Public: (01)10852528005053(17)230131(10)306420
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 70056-06
• Device Lot Number: 306420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2020
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Race: Black Or African American