MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED STEALTH; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	PRD-SC30-125
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Device-Device Incompatibility (2919); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H10: the command guide wire referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the stealth 360 peripheral orbital atherectomy device (oad) was used with the abbott command guide wire.The 60-70% stenosed popliteal artery post intravascular ultrasound (ivus) was treated successfully.The oad was then advanced distally to the calcified, 70-80% stenosed posterior tibial (pt) artery.The oad stalled in the distal pt.The command wire became stuck on the oad and had to be removed together causing loss of wire access.A small perforation was observed in the distal pt where the oad crown stalled.Planned plain old balloon angioplasty (poba) was performed to resolve the perforation.The patient was stable.While ex vivo, the physician was able to remove the command wire out of the oad.The physician understood using the command wire with the oad is off label and the instructions for use (ifu) was not difficult to read/understand.The physician was alleging malfunction of the oad.
Event or Problem Description
It was reported that the stealth 360 peripheral orbital atherectomy device (oad) was used with the abbott command guide wire.The 60-70% stenosed popliteal artery post intravascular ultrasound (ivus) was treated successfully.The oad was then advanced distally to the calcified, 70-80% stenosed posterior tibial (pt) artery.The oad stalled in the distal pt.The command wire became stuck on the oad and had to be removed together causing loss of wire access.A small perforation was observed in the distal pt where the oad crown stalled.Planned plain old balloon angioplasty (poba) was performed to resolve the perforation.The patient was stable.While ex vivo, the physician was able to remove the command wire out of the oad.The physician understood using the command wire with the oad is off label and the instructions for use (ifu) was not difficult to read/understand.The physician was alleging malfunction of the oad.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot- specific issue.Based on the information received, the investigation determined that the reported perforation of vessels, unexpected shutdown, difficult to remove, resulting in unexpected medical intervention appear to be related to user error.In this case it is possible that the reported perforation of vessels, unexpected shutdown, difficult to remove, resulting in unexpected medical intervention are due to use of the oad with the command guide wire which is off-label use.The stealth peripheral instruction for use (ifu), warns: "the device is designed to track and spin only over the csi viperwire advance peripheral guide wire or the viperwire advance with flex tip peripheral guide wire.Do not use any other guide wire with this device".In this case, the violation of the ifu likely contributed to the reported difficulties.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Updated: g3, g6, h2, h6.H6: codes 4118, 3233, and 11 no longer apply.H10: the command guide wire referenced in b5 is filed under a separate medwatch report number.

• Brand Name: STEALTH
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3008814558; 14740 kirby dr; houston TX 77047
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 23211158
• Report Number: 3004742232-2025-00294
• Device Sequence Number: 8919331
• Product Code: MCW
• UDI-Device Identifier: 10850000491271
• UDI-Public: (01)10850000491271(17)270331(10)568577-1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K220568
• 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,Followup
• Report Date (Section B): 10/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 7-10059-02
• Device Lot Number: 568577-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ORBITAL ATHERECTOMY DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic