MAUDE Adverse Event Report: ARTHROCARE CORPORATION 5.5CM ANTERIOR; BALLOON, EPISTAXIS

Catalog Number	RR 550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during an ent procedure, the balloon tube at the base of the 5.5 cm rapid rhino device broke during removal.It was necessary to remove the device using long-nose forceps through the nose.The procedure was then completed using the same device.It is unknown whether there was any surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Additional information was provided.Sections a2, a3, a4, b5 and b7 were updated.
Event or Problem Description
It was reported that during an ent procedure, the balloon tube at the base of the 5.5 cm rapid rhino device broke during removal.It was necessary to remove the device using long-nose forceps through the nose.The procedure was resumed, after a non-significant delay, using the same faulty device.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned with any original packaging.The nasal tube with fabric covering was returned used and deflated.The inflation tubing has detached from the neck of the nasal tube.The pilot ballon with a partial length of the inflation tubing was returned with no visible defect.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.Based on this investigation, the need for corrective action is not indicated.If any additional information related to this event is received in the future, this investigation will be reopened for further assessment.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the failure include procedural variance, or deviations from established protocols, increasing risks and leading to unintended consequences (impact event to the device inconsistent with normal use).Based on this investigation, the need for corrective action is not indicated.

• Brand Name: 5.5CM ANTERIOR
• Common Device Name: BALLOON, EPISTAXIS
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23888269
• Report Number: 3006524618-2025-00713
• Device Sequence Number: 9650137
• Product Code: EMX
• UDI-Device Identifier: 00817470006629
• UDI-Public: 817470006629
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: RR 550
• Device Lot Number: 2175833
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 03/06/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/08/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2025
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 75 KG