BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE BALLOON DILATOR V (WITH KNIFE)

    MDR report key: 20839505 · Received December 3, 2024

    Report

    Report Number
    9614641-2024-20043
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    June 5, 2024
    Report Date
    December 30, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170373978
    PMA / PMN Number
    K150142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITERATURE DESCRIBED STANDARD WIRE-GUIDED SPHINCTEROTOMES (CLEVERCUT, CLEVERCUT 3 V OR STONEMASTER V). OLYMPUS SELECTED ¿KD-211Q-0720¿, ¿KD-V411M-0725¿ AND ¿BD-VC431Q-1840-25¿, AS REPRESENTATIVE MODELS. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION FROM CUSTOMER AND FINAL INVESTIGATION. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT THERE IS NO CAUSAL RELATIONSHIP BETWEEN THE SUBJECT DEVICE AND ADVERSE EVENTS REPORTED IN THE LITERATURE. THE CUSTOMER CONFIRMED THAT THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY PATIENT COMPLICATIONS DESCRIBED IN THE LITERATURE. ADDITIONALLY, THERE WAS NO DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿PROPHYLACTIC USE OF A SELF-ASSEMBLING PEPTIDE HYDROGEL FOR PREVENTING DELAYED BLEEDING AFTER ENDOSCOPIC SPHINCTEROTOMY: A PROPENSITY SCORE-MATCHED ANALYSIS." BACKGROUND AND AIM: DELAYED ENDOSCOPIC SPHINCTEROTOMY-RELATED BLEEDING (ES BLEEDING) IS AN UNAVOIDABLE ADVERSE EVENT (AE) THAT CAN HAVE SERIOUS RAMIFICATIONS. INTRAOPERATIVE ES BLEEDING, WHICH STOPS SPONTANEOUSLY IN MOST CASES, IS A KNOWN RISK FACTOR FOR DELAYED BLEEDING. THIS STUDY AIMED TO EXAMINE THE PREVENTIVE EFFECT OF A NOVEL SELF-ASSEMBLING PEPTIDE (SAP) FOR DELAYED ES BLEEDING IN PATIENTS WHO ATTAINED SPONTANEOUS HEMOSTASIS AFTER INTRAOPERATIVE ES BLEEDING. METHODS: A TOTAL OF 1507 PATIENTS MET THE ELIGIBILITY CRITERIA FOR INCLUSION IN THIS STUDY. THE RATES OF DELAYED ES BLEEDING AND AE BESIDES BLEEDING WERE COMPARED BETWEEN PATIENTS ADMINISTERED THE SAP (SAP GROUP) AND THOSE WHO WERE SIMPLY OBSERVED AFTER SPONTANEOUS HEMOSTASIS OF INTRAOPERATIVE ES BLEEDING (CONTROL GROUP). PROPENSITY SCORE MATCHING WAS PERFORMED TO ADJUST FOR DIFFERENCES BETWEEN THE GROUPS. RESULTS: THE RATE OF DELAYED ES BLEEDING WAS SIGNIFICANTLY LOWER IN THE SAP GROUP THAN THAT IN THE CONTROL GROUP (0.9% VS 3.8%, P = 0.044). THE RATES OF AES OTHER THAN BLEEDING WERE 2.4% AND 3.8% IN THE SAP AND CONTROL GROUPS, RESPECTIVELY, AND THE DIFFERENCE LACKED STATISTICAL SIGNIFICANCE (P = 0.481). MULTIVARIATE ANALYSIS REVEALED THAT THE USE OF SAP WAS SIGNIFICANTLY ASSOCIATED WITH A LOWER FREQUENCY OF DELAYED ES BLEEDING (ODDS RATIO, 0.35; 95% CONFIDENCE INTERVAL, 0.13¿0.98; P = 0.047). IN THE SAP GROUP, THE TWO BLEEDING EVENTS WERE MILD AND WERE STOPPED WITH AN ENDOSCOPIC EPINEPHRINE INJECTION. IN THE CONTROL GROUP, THE SEVERITY OF BLEEDING WAS MILD IN 2 PATIENTS, MODERATE IN 12, AND SEVERE IN 2 (FIG. 2). ALL THESE CASES UNDERWENT ENDOSCOPIC HEMOSTASIS WITH VARIOUS METHODS, AND SEVEN OF THEM REQUIRED A COVERED METAL STENT PLACEMENT; ONE CASE REQUIRED ARTERIAL EMBOLIZATION AS THE BLEEDING COULD NOT BE STOPPED ENDOSCOPICALLY. THE RATES OF AES OTHER THAN BLEEDING WERE 2.4% (5/212) AND 3.8% (16/424) IN THE SAP AND CONTROL GROUPS, RESPECTIVELY; THE DIFFERENCE WAS NOT STATISTICALLY SIGNIFICANT (P = 0.481). OTHER AES THAT WERE IDENTIFIED IN THE SAP GROUP INCLUDED PANCREATITIS IN TWO PATIENTS, CHOLANGITIS IN TWO PATIENTS, AND ASPIRATION PNEUMONITIS IN ONE PATIENT; THESE WERE ALL TREATED CONSERVATIVELY. AES IN THE CONTROL GROUP INCLUDED PANCREATITIS IN 10 PATIENTS, ASPIRATION PNEUMONITIS IN 3, AND PERFORATION IN 3; FIVE PANCREATITIS CASES AND ONE PERFORATION CASE WERE SEVERE, WHILE THE OTHER EVENTS WERE GRADED AS MILD OR MODERATE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [SAP GROUP], DELAYED BLEEDING AFTER ES - 2 PATIENTS (MODERATE = 2), PANCREATITIS - 2 PATIENTS, CHOLANGITIS - 2 PATIENTS, ASPIRATION PNEUMONITIS - 1 PATIENT. [CONTROL GROUP], DELAYED BLEEDING AFTER ES - 16 PATIENTS (MILD = 2,MODERATE = 12, SEVERE = 2), PANCREATITIS - 10 PATIENTS, ASPIRATION PNEUMONITIS - 3 PATIENTS, PERFORATION - 3 PATIENTS. CONCLUSIONS: SELF-ASSEMBLING PEPTIDE MAY BE A SIMPLE, SAFE, AND USEFUL WAY TO REDUCE THE RISK OF DELAYED ES BLEEDING IN PATIENTS WHO EXPERIENCED INTRAOPERATIVE ES BLEEDING AND OBTAINED SUBSEQUENT SPONTANEOUS HEMOSTASIS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE AND HAS NOT CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT ADVERSE EVENTS DESCRIBED IN THE LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070882 SINGLE USE BALLOON DILATOR V (WITH KNIFE) BALLOON DILATOR KNS AOMORI OLYMPUS CO., LTD. BD-VC431Q-1840-25 NI 04953170373978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention DUODENOSCOPE