BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM

    MDR report key: 14830857 · Received June 27, 2022

    Report

    Report Number
    3005172759-2022-00014
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    April 8, 2022
    Report Date
    June 27, 2022
    Manufacturer
    ACCLARENT, INC.
    Product Code
    QGK
    UDI-DI
    10705031462649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT A PHYSICIAN COMMENTED THAT HE RECEIVED A PATIENT WITH A SEPTAL HEMATOMA AFTER UNDERGOING A PROCEDURE WITH A RELIEVA TRACT PROCEDURE TO ADDRESS NASAL OBSTRUCTION. THE PHYSICIAN DRAINED THE PATIENT AND THE HEMATOMA WAS RESOLVED. ON 20-JUN-2022, DETAILED ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ON (B)(6) 2022, A MALE PATIENT UNDERWENT A BALLOON SINUPLASTY PROCEDURE TO TREAT THE SINUS ISSUE AND A RELIEVA TRACT BALLOON (RT1640A / LOT# UNKNOWN) WAS USED DURING THE PROCEDURE TO CREATE SPACE. THE SEPTAL HEMATOMA WAS ASSUMED TO HAVE OCCURRED ON (B)(6) 2022. IT WAS CONFIRMED ON POST-OPERATIVE DAY 8 BY DR. (B)(6) ON COMPUTED TOMOGRAPHY (CT) IMAGING ON (B)(6) 2022. THE PATIENT DID NOT HAVE ANY PREVIOUS SINUS TREATMENT BEFORE THE INDEX BSP PROCEDURE OR WITH THE RELIEVA TRACT; IT IS UNKNOWN IF THE PATIENT HAS A HISTORY OF HEMATOMAS. IN THE PHYSICIAN¿S OPINION, THE PROCEDURE RISK AND SUBMUCOSAL RUPTURE MAY HAVE CAUSED OR CONTRIBUTED TO THE SEPTAL HEMATOMA. THE SEPTAL HEMATOMA WAS TREATED VIA SUCCESSFUL OPERATIVE INCISION AND DRAINAGE (I&D). THE DRAINAGE WAS COMPLETED IN ONE VISIT. THE PATIENT IS REPORTED TO BE DOING WELL AND WAS NOT HOSPITALIZED. THE RELIEVA TRACT WAS DILATED ONE TIME PER SIDE. THERE WAS NO DIFFICULTY MANIPULATING THE TRACT BALLOON OR ACCESSING THE SINUS DURING THE PROCEDURE. THERE WAS NO DEVICE PERFORMANCE ISSUE OR MALFUNCTION RELATED TO THE RELIEVA TRACT DURING THE PROCEDURE; THE PROCEDURE INVOLVING THE TRACT BALLOON WAS CONSIDERED SUCCESSFUL. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. SEPTAL HEMATOMA IS A PROCEDURE RISK. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR DEVICE MALFUNCTION RELATED TO THE EVENT. SINCE THE SEPTAL HEMATOMA IS A SERIOUS INJURY AND THE EVENT REQUIRED SURGICAL INTERVENTION VIA THE OPERATIVE INCISION AND DRAINAGE (I&D) TO PRECLUDE PERMANENT IMPAIRMENT, THE EVENT MEETS MDR REPORTING CRITERIA. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ACCLARENT, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ACCLARENT, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT A PHYSICIAN COMMENTED THAT HE RECEIVED A PATIENT WITH A SEPTAL HEMATOMA AFTER UNDERGOING A PROCEDURE WITH A RELIEVA TRACT PROCEDURE TO ADDRESS NASAL OBSTRUCTION. THE PHYSICIAN DRAINED THE PATIENT AND THE HEMATOMA WAS RESOLVED. ON 20-JUN-2022, DETAILED ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ON (B)(6) 2022, A MALE PATIENT UNDERWENT A BALLOON SINUPLASTY PROCEDURE TO TREAT THE SINUS ISSUE AND A RELIEVA TRACT BALLOON (RT1640A / LOT# UNKNOWN) WAS USED DURING THE PROCEDURE TO CREATE SPACE. THE SEPTAL HEMATOMA WAS ASSUMED TO HAVE OCCURRED ON (B)(6) 2022. IT WAS CONFIRMED ON POST-OPERATIVE DAY 8 BY DR. (B)(6) ON COMPUTED TOMOGRAPHY (CT) IMAGING ON (B)(6) 2022. THE PATIENT DID NOT HAVE ANY PREVIOUS SINUS TREATMENT BEFORE THE INDEX BSP PROCEDURE OR WITH THE RELIEVA TRACT; IT IS UNKNOWN IF THE PATIENT HAS A HISTORY OF HEMATOMAS. IN THE PHYSICIAN¿S OPINION, THE PROCEDURE RISK AND SUBMUCOSAL RUPTURE MAY HAVE CAUSED OR CONTRIBUTED TO THE SEPTAL HEMATOMA. THE SEPTAL HEMATOMA WAS TREATED VIA SUCCESSFUL OPERATIVE INCISION AND DRAINAGE (I&D). THE DRAINAGE WAS COMPLETED IN ONE VISIT. THE PATIENT IS REPORTED TO BE DOING WELL AND WAS NOT HOSPITALIZED. THE RELIEVA TRACT WAS DILATED ONE TIME PER SIDE. THERE WAS NO DIFFICULTY MANIPULATING THE TRACT BALLOON OR ACCESSING THE SINUS DURING THE PROCEDURE. THERE WAS NO DEVICE PERFORMANCE ISSUE OR MALFUNCTION RELATED TO THE RELIEVA TRACT DURING THE PROCEDURE; THE PROCEDURE INVOLVING THE TRACT BALLOON WAS CONSIDERED SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910096 RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM BALLOON, NASAL AIRWAY QGK ACCLARENT, INC. RT1640A 10705031462649

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Unknown Required Intervention