BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON DILATOR "BA-2 ACHALASIA BAL DIL", 35 X 100 MM BALLOON, 1000 MM LENGTH

    MDR report key: 13422920 · Received February 2, 2022

    Report

    Report Number
    3003790304-2022-00023
    Event Type
    Injury
    Date Received
    February 2, 2022
    Report Date
    May 3, 2022
    Manufacturer
    HOBBS MEDICAL INC.
    Product Code
    FGE
    PMA / PMN Number
    K050502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO PROVIDE INVESTIGATION FINDINGS. NEW INFORMATION IS REPORTED IN H6 AND H10. PHYSICAL EVALUATION OF THE SUSPECT DEVICE COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED TO OLYMPUS. ANALYSIS: OLYMPUS REVIEWED A STUDY TITLED ¿RESOLUTION OF SYMPTOMS AFTER HELLER'S CARDIOMYOTOMY WITH DOR FUNDOPLICATION VERSUS ENDOSCOPIC BALLOON DILATATION IN PATIENTS WITH ACHALASIA CARDIA AT (B)(6) HOSPITAL¿. HOWEVER, NO DEFECT/MALFUNCTION OF THE PRODUCT STATED IN THIS COMPLAINT HAS BEEN REPORTED. AS A RESULT, THE REPORTED ITEM MEETS ITS SPECIFICATION. DHR REVIEW: IT IS IMPOSSIBLE TO PERFORM A DHR REVIEW WITH A MISSING LOT NUMBER. INSTEAD, THE MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE LAST 24 MONTHS OF PRODUCTION WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUE. THE DEFINITIVE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. OF NOTE, NO DEVICE MALFUNCTION WAS REPORTED.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE STUDY LITERATURE TITLED ¿RESOLUTION OF SYMPTOMS AFTER HELLER'S CARDIOMYOTOMY WITH DOR FUNDOPLICATION VERSUS ENDOSCOPIC BALLOON DILATATION IN PATIENTS WITH ACHALASIA CARDIA AT TERTIARY CARE HOSPITAL¿, TWO PATIENTS EXPERIENCED PERFORATION AFTER AN ENDOSCOPIC BALLOON DILATION PROCEDURE USING TWO OLYMPUS ACHALASIA BALLOON DILATORS (BA-1, 30MM, AND BA-2, 35MM). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE BA-1, 30MM; CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS DEVICE BA-1, 35MM. STUDY AIM: TO COMPARE IMPROVEMENT IN SYMPTOMS FOLLOWING HELLER'S MYOTOMY WITH DOR FUNDOPLICATION AND ENDOSCOPIC PNEUMATIC DILATATION FOR THE TREATMENT OF ACHALASIA CARDIA. STUDY METHOD: PROSPECTIVE COMPARATIVE STUDY WAS PERFORMED FROM FEBRUARY 2016 TO JANUARY 2019, INCLUDING PATIENTS DIAGNOSED WITH ACHALASIA CARDIA ON ESOPHAGEAL MANOMETRY. THE SUBJECTS WERE RANDOMIZED INTO ENDOSCOPIC PNEUMATIC DILATATION GROUP A, AND LAPAROSCOPIC HELLER'S MYOTOMY WITH DOR FUNDOPLICATION GROUP B. STUDY RESULTS: OF THE 42 PATIENTS, 21 (50%) WERE IN EACH OF THE TWO GROUPS. TREATMENT SUCCESS IN GROUP A WAS 11 (52%) COMPARED TO 21 (76%) IN GROUP B. N: THE EFFICACY OF HELLER'S MYOTOMY WITH DOR FUNDOPLICATION WAS FOUND TO BE GREATER THAN ENDOSCOPIC PNEUMATIC DILATATION FOR IMPROVEMENT IN DYSPHAGIA AND OVERALL PATIENT SATISFACTION AT ONE-YEAR FOLLOW-UP. BOTH PATIENTS EXPERIENCING PERFORATIONS IN THE PNEUMATIC DILATION (PD) GROUP WERE MANAGED CONSERVATIVELY AND THE PATIENTS WERE SUBSEQUENTLY DISCHARGED WITHOUT ANY FURTHER CONSEQUENCES. THERE WAS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126926 BALLOON DILATOR "BA-2 ACHALASIA BAL DIL", 35 X 100 MM BALLOON, 1000 MM LENGTH CATHETER, BILIARY, DIAGNOSTIC FGE HOBBS MEDICAL INC. WA95091A UNKNOWN-LITERATURE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O BA-1, 30MM.