BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIFLEX II ACHALASIA BALLOON DILATOR

    MDR report key: 2274813 · Received October 4, 2011

    Report

    Report Number
    3005099803-2011-03441
    Event Type
    Malfunction
    Date Received
    October 4, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 13, 2011
    Manufacturer
    TECHDEVICE CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K050232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER WAS FOUND STAMPED ON THE RETURNED COMPLAINT DEVICE, THEREFORE THE DEVICE EXPIRATION AND MANUFACTURED DATES ARE NOW KNOWN. INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED NO DEFECTS. FUNCTIONAL TESTING WAS PERFORMED; THE BALLOON WAS INFLATED PER SPECIFICATION AND NO LEAKS WERE OBSERVED. THE DEVICE HELD PRESSURE WITH NO ISSUES. THE DEVICE ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT THAT THE DEVICE WAS DIFFICULT TO REMOVE FROM THE PATIENT ANATOMY, HOWEVER IT IS POSSIBLE THIS EVENT OCCURRED DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. REPORTED EVENT OF DIFFICULTY REMOVING BALLOON FROM PATIENT ANATOMY. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A RIGIFLEX II BALLOON DILATOR WAS USED DURING A DILATATION PROCEDURE OF THE CARDIAC PORTION OF THE ESOPHAGUS PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE DILATATION WAS COMPLETED WITH THIS DEVICE; HOWEVER, WHEN REMOVING THE DEVICE, THE BALLOON WAS CAUGHT BY THE UPPER ESOPHAGUS AND WAS DIFFICULT TO REMOVE FROM THE PATIENT ANATOMY. IT WAS REPORTED THE BALLOON WAS COMPLETELY DEFLATED PRIOR TO WITHDRAWAL AND NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. IT WAS CONFIRMED THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A RIGIFLEX II BALLOON DILATOR WAS USED DURING A DILATATION PROCEDURE OF THE CARDIAC PORTION OF THE ESOPHAGUS PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE DILATATION WAS COMPLETED WITH THIS DEVICE; HOWEVER WHEN REMOVING THE DEVICE, THE BALLOON WAS CAUGHT BY THE UPPER ESOPHAGUS AND WAS DIFFICULT TO REMOVE FROM THE PATIENT ANATOMY. IT WAS REPORTED THE BALLOON WAS COMPLETELY DEFLATED PRIOR TO WITHDRAWAL AND NO VISIBLE ISSUES WERE NOTED TO THE DEVICE. IT WAS CONFIRMED THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIFLEX II ACHALASIA BALLOON DILATOR DILATOR, ESOPHAGEAL KNQ TECHDEVICE CORPORATION M00554520 73562

    Patients

    Seq Age Sex Outcome Treatment
    1