MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ARCADIA¿; ARTHORSCOPE

Catalog Number	ARC15SB
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that the kyphoplasty balloons were deployed into the vertebral bodies of the t12 vertebra under fluoroscopic guidance and satisfactory balloon fill was noted at each level bilaterally.On the right side, during balloon inflation, the balloon ruptured despite no pressure over 400mhg.During removal of the balloon, the small platinum-iridium marker was retained within the vertebral body.An intraoperative decision was made to leave the retained foreign object within the t12 body as retrieval would be more damaging, dangerous, and invasive than the risks of leaving the retained object within.A decision was made not to cement the right side of the body as there was potential for lateral side wall fracture during balloon rupture.On the back table, bone cement was mixed and after withdrawal of the balloons from the vertebrae, the bone cement was injected under fluoroscopic guidance into the t12 vertebrae bilaterally with excellent bone fill, showing fracture fill with the cement.After withdrawal of the kyphoplasty cannula, ap x-rays were taken demonstrating excellent bone fill at t12.No patient injury.

• Brand Name: ARCADIA¿
• Common Device Name: ARTHORSCOPE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut 84095 ; EI 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22521299
• Report Number: 9616662-2025-00023
• Device Sequence Number: 8058942
• Product Code: HRX
• UDI-Device Identifier: 00884450815489
• UDI-Public: 00884450815489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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?: Yes
• Device Catalogue Number: ARC15SB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown