MAUDE Adverse Event Report: ARTHROCARE CORPORATION 9CM ANTERIOR/POSTERIOR DUAL; BALLOON, EPISTAXIS

Catalog Number	RR 900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ent procedure, the patient in question had bilateral packs in situ and was struggling to breathe due to an obstruction in the back of the throat.After inspection, it was noticed the rapid rhino had separated into two pieces and had to be removed in response to the emergency.It is unknown if there was a backup device available or if there was a surgical delay.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an analysis of the customer provided images found two unlabeled photos that confirm that the rapid rhino was separated into two pieces, but does not provide a clinical root cause of the adverse event.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.Based on the information available, 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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states that clinical factors which could have contributed to the reported adverse event could not be definitively concluded, therefore, a causal relationship between the smith and nephew¿s rapid rhino and the reported adverse event could not be established with the limited information provided.The impact to the patient beyond that which has already been reported is unknown since the patient¿s outcome was not reported.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: 9CM ANTERIOR/POSTERIOR DUAL
• 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: 18663893
• Report Number: 3006524618-2024-00056
• Device Sequence Number: 8002474
• Product Code: EMX
• UDI-Device Identifier: 00817470000504
• UDI-Public: 00817470000504
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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 Catalogue Number: RR 900
• Device Lot Number: UNKNOWN
• 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: 01/18/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown