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

Catalog Number	RR 750
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an unknown procedure the patient was packed bi-laterally with rapid rhino following tumour de-bulking procedure.They don¿t know when and if the balloon was inflated.As the patient was waking, they observed that the patient had difficulty breathing.They removed the rapid rhino and observed that it appear to have come apart.The piece in the laryngopharnxy was removed under laryngoscopy.They also removed more material from the nasal airway under endoscopy.Immediate de -gloving of rapid rhino pack with alginate and ending up in laryngeal inlet.Patient could not breath, laryngoscopy was performed to remove alginate from laryngeal inlet, and the nose was packed with bipp (bismuth iodine paraffine paste).
Event or Problem Description
It was reported that during an anterior/posterior nasal bleed the patient was packed bi-laterally with rapid rhino following tumour de-bulking procedure.They dont know when and if the balloon was inflated.As the patient was waking, they observed that the patient had difficulty breathing.They removed the rapid rhino and observed that it appear to have come apart.The piece in the laryngopharynx was removed under laryngoscopy.They also removed more material from the nasal airway under endoscopy.Immediate de -gloving of rapid rhino pack with alginate and ending up in laryngeal inlet.Patient could not breath, laryngoscopy was performed to remove alginate from laryngeal inlet, and the nose was packed with bipp (bismuth iodine paraffine paste).
Additional Manufacturer Narrative
Per information received by the reporter this report is a duplicate from report 3006524618-2019-00189.

• Brand Name: 7.5CM ANTERIOR/POSTERIOR
• Common Device Name: BALLOON, EPISTAXIS
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8520496
• Report Number: 3006524618-2019-00190
• Device Sequence Number: 16833985
• Product Code: EMX
• UDI-Device Identifier: 00817470006636
• UDI-Public: 00817470006636
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2019

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 Catalogue Number: RR 750
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/18/2019; 04/25/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 04/22/2019; 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1