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

Model Number	DBE-200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2025
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.
Event or Problem Description
It was reported that a 6fr sheath to dorsalis pedis for pedal access was gained and a 2.0 classic diamondback peripheral orbital atherectomy device (oad) was advanced to 90% stenosed, heavily calcified, non tortuous proximal anterior tibial (at) for treatment.The vessel diameter was 3.5 mm.The sound of device bogging down was heard and when the physician pulled the oad, it was unsuccessful.Several attempts were made to pull it out, but it was unable to remove the oad.The catheter was cut off the device and attempted to remove again, but it failed.After several more attempts, the catheter separated and an attempt was made to snare the crown out, but was unsuccessful.The crown was stuck in distal anterior tibial artery and a stent was placed over the crown to keep it in place.It was unknown why the oad was stuck.The patient was discharged the same day and was stable.
Event or Problem Description
It was reported that a 6fr sheath to dorsalis pedis for pedal access was gained and a 2.0 classic diamondback peripheral orbital atherectomy device (oad) was advanced to 90% stenosed, heavily calcified, non tortuous proximal anterior tibial (at) for treatment.The vessel diameter was 3.5 mm.The sound of device bogging down was heard and when the physician pulled the oad, it was unsuccessful.Several attempts were made to pull it out, but it was unable to remove the oad.The catheter was cut off the device and attempted to remove again, but it failed.After several more attempts, the catheter separated and an attempt was made to snare the crown out, but was unsuccessful.The crown was stuck in distal anterior tibial artery and a stent was placed over the crown to keep it in place.It is unknown why the oad was stuck.The patient was discharged the same day and was stable.
Additional Manufacturer Narrative
A visual inspection, functional testing, dimensional analysis and detailed analysis was performed on the returned device.The reported entrapment of device, foreign body in patient, and unexpected medical intervention could not be confirmed through analysis due to the operational context of the reported complaints.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 reported information and the observations from the returned analysis, the investigation determined that the reported stuck driveshaft appears to be related to circumstances of the procedure.The oad was returned with the driveshaft and engaged guide wire cut.The distal driveshaft and guide wire segments were not returned for analysis.Engineering review of the device data log showed that the 5th and 6th spin on low speed ended in a stall.It is unknown if the stall events in the data log are related to the stuck device.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 fields: d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions, component code), h11.

• 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: 23144867
• Report Number: 3004742232-2025-00285
• Device Sequence Number: 21311493
• Product Code: MCW
• UDI-Device Identifier: 10850000491349
• UDI-Public: (01)10850000491349(17)270430(10)571055-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/13/2025

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: DBE-200
• Device Catalogue Number: 7-10059-09
• Device Lot Number: 571055-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic