MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB BALLOON APPLICATOR KIT; BALLOON APPLICATOR, 3-4 CM SPHERICAL

Model Number	720788
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Death
Event or Problem Description
The customer reported a case of potential severe toxicity.The patient was found deceased shortly after surgery/irradiation.It is assumed that the cause may have been a pulmonary embolism rather than a cerebral event; however, this ultimately remains unclear, as an autopsy was declined by the family.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H6 updated.H11 updated: the investigation was completed by conducting a thorough evaluation of the reported information.The customer reported a case of potential severe toxicity.The patient was found deceased shortly after surgery/irradiation.It is assumed that the cause may have been a pulmonary embolism rather than a cerebral event; however, this ultimately remains unclear, as an autopsy was declined by the family.Elekta have engaged in ongoing discussions with the customer and based on the limited information available, elekta have not identified any indication of product performance issues associated with our products.Elekta conducted additional testing using balloons and a controller from a different lot/serial number to assess whether pressure/force may have contributed to the reported adverse event.The results of this evaluation did not demonstrate that the device could have contributed to the event.

• Brand Name: BALLOON APPLICATOR KIT
• Common Device Name: BALLOON APPLICATOR, 3-4 CM SPHERICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 24740286
• Report Number: 3015232217-2026-00007
• Device Sequence Number: 9835301
• Product Code: JAD
• UDI-Device Identifier: 00858012005311
• UDI-Public: 00858012005311
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 720788
• Device Catalogue Number: AB2060
• Device Lot Number: 2435101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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: Death
• Patient Sex: Unknown