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

Model Number	PRD-SC30-125
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported oad and guide wire were received at csi for analysis.Visual examination revealed a hole in the saline sheath.Fluid was observed leaking at the damaged site during analysis.Measurable flow was observed at the distal end of the sheath, although it was reduced due to the hole.The oad was tested and found to have functioned as intended.The damage was likely caused during handling or interaction with an accessory; however, this could not be conclusively confirmed, and the root cause of the damage remains undetermined.The guide wire was passed through the oad with no resistance.At the conclusion of the investigation, the report of leaking fluid was confirmed; however, the report of the oad being stuck on the guide wire was unable to be conclusively 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.Csi id# (b)(4).
Event or Problem Description
A stealth peripheral orbital atherectomy device (oad) was selected for treatment of a 100% stenosed, severely calcified lesion in the tibioperoneal trunk (tpt) and peroneal artery.Four treatments on low speed were performed in the tpt and high speed treatments were started in the peroneal artery.The oad became stuck on the guide wire, and the oad and guide wire were removed together.A pin hole was noted in the saline sheath, and a majority of the viperslide was spraying out.No patient complication was reported.The procedure was completed with balloon 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
• MDR Report Key: 12348389
• Report Number: 3004742232-2021-00295
• Device Sequence Number: 14749870
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)221231(10)360008-1
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 12/31/2022
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 360008-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 77