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

Catalog Number	RR 750
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vomiting (2144); Epistaxis (4458); Swelling/ Edema (4577)
Date of Event	07/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an ent procedure with rhino rockets placed in bilateral nares for stopping blood flow from nose, patient became sick and started vomiting large clots.The physician removed rhino rocket from nares, but the left one was missing the absorbable tamponade of the device.It had somehow detached from the bulb of the device.Tamponade was not found on the patient, in patient bed or in emesis of patient.X-rays of the abdomen and chest neither showed the piece of the device anywhere in the patient.Patient was transferred to another facility due to heavy epistaxis.Patient discharged.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that after an ent procedure with rhino rockets placed in bilateral nares for stopping blood flow from nose after a fall, patient became sick and started vomiting large clots after 4 hours with the rhino rockets.The physician removed rhino rocket from nares, but the left one was missing the absorbable tamponade of the device.It had somehow detached from the bulb of the device.Tamponade was not found on the patient, in patient bed or in emesis of patient.X-rays of the abdomen and chest neither showed the piece of the device anywhere in the patient.Patient was transferred to another facility due to heavy epistaxis.Patient had a nosebleed in the er.Ct of face showed bilateral periorbital swelling, a midline frontal region hematoma.Patient discharged.
Additional Manufacturer Narrative
H10: h3, h6: 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.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.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 all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided the clinical root cause of the reported rapid rhino tamponade detachment could not be determined.The device instructions for use notes to ¿monitor the device for any sign of deflation, which can cause dislodgement of the nasal catheter.¿ the reported nosebleed, vomiting, and ct results (swelling and hematoma) are consistent with symptoms from a trauma, therefore, the reported patient fall could not be ruled out as a contributing factor to the reported symptoms.Although it was reported the patient was discharged home, the status of the patient is unknown.Therefore, the patient impact beyond the reported events could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.Corrected data: h6: health effect - clinical and impact code.

• 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: 17511454
• Report Number: 3006524618-2023-00317
• Device Sequence Number: 15502215
• Product Code: EMX
• UDI-Device Identifier: 00817470006636
• UDI-Public: 00817470006636
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2023

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 Expiration Date: 01/31/2026
• Device Catalogue Number: RR 750
• Device Lot Number: 2112581
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 11/23/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/04/2023; 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 95 KG