MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) STEALTH; STEALTH 360 ORBITAL ATHERECTOMY DEVICE

Model Number	DBE-150
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Noise, Audible (3273); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).
Event or Problem Description
A stealth 360 peripheral orbital atherectomy device (oad) was used for treatment of lesion in distal superficial femoral artery (sfa) via right common femoral artery (cfa) approach.The vessel diameter was 5-6mm.A 5fr guiding sheath was advanced but replaced with 6fr 45 cm guiding sheath for longer access and stability.Using the 6fr guiding sheath for support, a.014 non-csi guide wire was used to cross the lesion.The 6 fr sheath was exchanged with.014 catheter.The guide wire was replaced with viperwire and the oad was successfully advanced to the distal sfa.Following the second atherectomy treatment in distal sfa which was on medium speed, the lesion was engaged, and a high-pitch noise was heard.The oad stopped spinning, but the oad led lights remained lit.The physician started to remove the oad, but observed under fluoroscopy that the crown has fractured and was stuck in distal sfa.It is unknown if the detachment occurred while pulling the oad for removal.A 2.0 x 540 balloon of unknown brand was used to successfully snare the detached crown.Upon removal, the balloon was found stuck on the fractured component.No fractured component was left in vivo.Balloon angioplasty using a 5.0 balloon of unknown brand was used to complete the procedure.After the six-hour procedure, the patient was stable and kept in hospital for additional 3 hours for bed rest.An hour of the delay was clinically significant to the procedure.The patient was discharged with no further complications.
Additional Manufacturer Narrative
The oad was returned with the crown detached.Scanning electron microscopy (sem) analysis of the driveshaft crown section showed minimal amounts of residual solder.Review of the device data log did not identify any compelling evidence of unusual stress or abuse of the device.There were 1.63 minutes of spin time and one speed-drop event.There were no stall events.The root cause of the crown separation was determined to be an insufficient solder bond during the manufacturing process.Csi id: (b)(4).

• Brand Name: STEALTH
• Common Device Name: STEALTH 360 ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19978075
• Report Number: 3004742232-2024-00307
• Device Sequence Number: 12797198
• Product Code: MCW
• UDI-Device Identifier: 10850000491332
• UDI-Public: (01)10850000491332(17)260131(10)522859-1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/05/2024

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: 01/31/2026
• Device Model Number: DBE-150
• Device Catalogue Number: 7-10059-08
• Device Lot Number: 522859-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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; Other; Hospitalization
• Patient Sex: Unknown