MAUDE Adverse Event Report: ARTHROCARE CORP. NASASTENT; SPLINT, INTRANASAL SEPTAL

Model Number	RR1000
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Headache (1880); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, after a nasal surgery, the patient was complaining of a severe pain and headache.The "rapid rhino, dissolvable nasal dressing" was not dissolving after following hydration guidelines and trimming method.This issue was detected after nasal surgeries and no delays or other complications were reported.The current status of the patient its unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported, that after a functional endoscopic sinus surgery.The patient was complaining of a severe pain headache.The "rapid rhino, dissolvable nasal dressing" was not dissolving.And had to be removed by suction, despite a nasal spray was used for (b)(6) weeks.This issue was detected after nasal surgeries.And no delays, patient injuries or other complications were reported.The patient recovered from pain and headache after removal of the nasastent.And without any further treatment.
Additional Manufacturer Narrative
H10 h3, h6 the reported device, intended for use treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection of the foil pouch found no defect to the device primary packing.The visual inspection of the device inside the pouch also did not find any defect.A functional evaluation found the nasastent device stayed in contact with the walls of the model through the incubation time confirming at least 72 hours residence time.The device also absorbed fluid from the nasal chamber and turned into gel over the same time-period.The nasastent device that has turned into a gel can be removed from the nasal model by suction and irrigation.The nasastent tested meets all the requirements of minimum residence time, absorbs fluids turns into hydrocolloidal gel, and can be removed by suction and irrigation.A clinical/medical evaluation determined that based on the information provided via e-mail such as the noting that the dressing ¿was not dissolving¿ and only using nasal spray, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of risk management files found that the reported failure was documented appropriately.The instructions for use was 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.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.

• Brand Name: NASASTENT
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11758651
• Report Number: 3006524618-2021-00540
• Device Sequence Number: 19692522
• Product Code: LYA
• UDI-Device Identifier: 00817470004946
• UDI-Public: 00817470004946
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2021

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: 07/30/2022
• Device Model Number: RR1000
• Device Catalogue Number: RR1000
• Device Lot Number: 2039143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/10/2021
• Supplement Date Received by Manufacturer: 05/04/2021; 05/21/2021
• Initial Report FDA Received Date: 05/01/2021
• Supplement Report FDA Received Date: 05/08/2021; 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other