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

Catalog Number	RR 900
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477); Blood Loss (2597); Foreign Body In Patient (2687)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that patient was waking from anesthesia and it was observed that patient had difficulty breathing.They removed the rapid rhino and it appeared to has come apart.The patient de saturated and blood could be heard gurgling.The piece in the laryngopharynx was removed under laryngoscopy.They also removed more material from the nasal airway under endoscopy.Patient is fully recovered.
Additional Manufacturer Narrative
The product was not returned for evaluation and had been used for treatment.A relationship, if any, between the product and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the product in question was not returned for evaluation.Thus, the customer¿s complaint could not be verified, nor could a root cause be determined with confidence.The instructions for use (ifu) provided with the device contains warnings and precautionary measures related to proper use of the device including but not limited to: - breathing distress is a possibility in physically small patients or patients with a shallow nasopharynx due to improper positioning of the device.- respiratory distress or decreased oxygenation can occur in patients at risk for impaired respiratory condition.- monitor the device for any sign of deflation, which can cause dislodgement of the nasal catheter.- over inflating the pvc balloon may result in: a) balloon rupture with possible trauma to nasal tissue, b) tissue necrosis due to excessive pressure.- do not exceed stated maximum volumes.Exceeding these volumes may cause the balloon to rupture.

• Brand Name: 9CM ANTERIOR/POSTERIOR DUAL
• Common Device Name: BALLOON, EPISTAXIS
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8519689
• Report Number: 3006524618-2019-00189
• Device Sequence Number: 13913296
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RR 900
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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