MAUDE Adverse Event Report: ARTHROCARE CORPORATION 7.5CM ANTERIOR/POSTERIOR; BALLOON, EPISTAXIS

Catalog Number	RR 750
Medical Device Problem Codes	Material Discolored (1170); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the device was received for evaluation at the manufacturing site; however, a physical product evaluation was not possible.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 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.The root cause of the reported event could not be determined.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.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the surgeon found discoloration on the package of the rapid rhino and thought it was just the packaging, and used the products on patient.However, after an ent procedure, while extracting out one product from patient the next day, the rapid rhino air inflation tube came off, leaving the balloon inside patient.The surgeon requested for tooth forceps to pull out the rapid rhino balloon after that.There was a non-significant surgical delay reported.No further complications were reported.
Additional Manufacturer Narrative
Corrections: h6 (type of investigation, investigation findings).Updated results of investigation: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.An analysis of the customer provided image found a blurry image making it impossible to confirm the part and lot numbers.However, it is possible to find yellowish discolorations on the packaging.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 identified similar reported events; however, no distinct trend has been observed for the reported event.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.

• Brand Name: 7.5CM ANTERIOR/POSTERIOR
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19563614
• Report Number: 3006524618-2024-00227
• Device Sequence Number: 20704995
• Product Code: EMX
• UDI-Device Identifier: 00817470006636
• UDI-Public: 00817470006636
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2026
• Device Catalogue Number: RR 750
• Device Lot Number: 2123281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 07/17/2024; 04/03/2025
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/22/2024; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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 Sex: Unknown