BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITIP CATHETER FOR HR GI

    MDR report key: 4508134 · Received January 16, 2015

    Report

    Report Number
    9710639-2015-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    July 25, 2014
    Report Date
    January 16, 2015
    Manufacturer
    UNISENSOR USA INC
    Product Code
    FFX
    PMA / PMN Number
    K062222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: AN ANORECTAL MANOMETRY INVESTIGATION WAS PERFORMED WITH A HIGH RESOLUTION CATHETER UNI-ANO-MO138 (B)(4) / K122345-L5-1175-D (B)(4), SERIAL NUMBER (B)(4). THE TIP OF THE UNISENSOR'S CATHETER WAS ATTACHED TO A (B)(4) TPE BALLOON ((B)(4) ITEM NUMBER A86-4300-10, LOT 1 AT 092413,2 AT 092713) FROM (B)(4) SCIENTIFIC (B)(4) SOLD TO USER FACILITY BY (B)(4) AND USING ELASTIC BANDS AND A FIXATION METHOD OF (B)(4) SCIENTIFIC (90-UFIX, LOT#130813) SOLD TO USER FACILITY BY (B)(4) (...) (B)(4) CLINICAL TRAINER WAS PRESENT FOR INITIAL PROCEDURE AND INSTRUCTED THE STAFF TO USE "NON-WAXED DENTAL FLOSS" TO SECURE THE BALLOON IN PLACE FOR FUTURE PROCEDURES DUE TO FAILURE OF THE ELASTIC BANDS TO PROPERLY SECURE BALLOON TO THE TIP OF THE CATHETER. (...) ADD'L MFR NARRATIVE: UNISENSOR IS THE MFR OF THE CATHETER WHICH WAS USED IN THE ANORECTAL INVESTIGATION TEST. THIS CATHETER CAN BE USED IN COMBINATION WITH ANY NUMBER OF PROD WHICH IN THIS CASE WERE NOT MANUFACTURED BY UNISENSOR. THE CATHETER ITSELF DID NOT MALFUNCTION AS THE CATHETER'S INTENDED USE IS THE EVALUATION AND DIAGNOSIS OF GASTROENTEROLOGICAL DYSFUNCTION RELATED TO MUSCLE TONUS AND THE COORDINATION OF CONTRACTIONS BETWEEN MUSCLE GROUPS, AND THERE IS NO INDICATION FROM THE INITIAL REPORT THAT THE MEDICAL DEVICE PERFORMED OUTSIDE ITS SPEC. THE ELASTIC BANDS IN COMBINATION WITH THE FIXATION METHOD MAY HAVE FAILED, BUT THESE PROD WERE NOT MFG BY UNISENSOR. ADDITIONALLY, THE COMPANY'S POST MARKET SURVEILLANCE RECORDS INDICATE THAT THE END USER MAY NOT HAVE PROPERLY DEFLATED THE BALLOON BEFORE EXTRACTION. ON THE SIDE OF UNISENSOR, NO CORRECTIVE OR REMEDIAL ACTION IS EXPECTED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    "TITLE: EVENT DESC: A HIGH RESOLUTION SYS HAS A BALLOON ATTACHED TO A CATHETER WITH TINY ELASTIC BANDS. UPON REMOVAL OF THE CATHETER THE BALLOON STAYED IN THE PT'S RECTUM. THE PT WAS TOLD TO TRY TO EVACUATE THE BALLOON WHILE TRYING TO MOVE HER BOWELS. NO BALLOON WAS RETURNED. THE PT WAS ENCOURAGED TO WATCH FOR BALLOON OVER THE WEEKEND. PT CHECKED HER STOOP OVER WEEKEND AND STILL DID NOT EXPEL THE BALLOON. SINCE THE PT DID NOT SEE THE BALLOON FROM RECTUM, SHE WAS INSTRUCTED TO RETURN TO ENDOSCOPY FOR A FLEXIBLE SIGMOIDOSCOPY TO CHECK FOR THE BALLOON PRESENCE. PT RETURNED AND BALLOON WAS RETRIEVED UNDER DIRECT VISUALIZATION WITHOUT COMPLICATIONS. REPRESENTATIVE WAS PRESENT FOR INITIAL PROCEDURE AND INSTRUCTED THE STAFF TO USE "NON-WAXED DENTAL FLOSS" TO SECURE THE BALLOON IN PLACE FOR FUTURE PROCEDURES. STAFF HAS PREFORMED PROCEDURE SUCCESSFULLY WITHOUT FLOSS IN PLACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40403 UNITIP CATHETER FOR HR GI HR UNITIP HIGH RESOLUTION CATHETER FFX UNISENSOR USA INC K122345-L5-1175-D

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other