BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE 3-LUMEN EXTRACTION BALLOON V

    MDR report key: 20346252 · Received October 1, 2024

    Report

    Report Number
    9614641-2024-01906
    Event Type
    Injury
    Date Received
    October 1, 2024
    Report Date
    December 16, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED EVENT WAS LIKELY AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A SURGICAL PROCEDURE WHILE USING THE SUBJECT DEVICE. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE AND NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER- 2429304-2024-0000428. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " ORLANDO PROTOCOL FOR SINGLE SESSION DUCTAL CLEARANCE OF COMMON BILE DUCT STONES AT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY ". OBJECTIVES: APPROACH TO MANAGEMENT OF COMMON BILE DUCT STONES (CBDS) BY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS NOT STANDARDIZED. WE EXAMINED OUTCOMES BY APPLYING PREDETERMINED PROTOCOL FOR CBDS MANAGEMENT. METHODS: WHEN STANDARD EXTRACTION TECHNIQUES FAILED AT ERCP, PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT RATIO WERE CALCULATED. LARGE BALLOON SPHINCTEROPLASTY (LBS) AND/OR MECHANICAL/SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY WAS PERFORMED BASED ON PRESENCE OF TAPERED BILE DUCT AND STONE-DUCT MISMATCH. PRIMARY OUTCOME WAS SINGLE-SESSION DUCTAL CLEARANCE. SECONDARY OUTCOME WAS ADVERSE EVENTS. RESULTS: OF 409 PATIENTS TREATED OVER 16 MONTHS, 321 (78.5%) HAD NO TAPERED BILE DUCT OR STONE-DUCT MISMATCH, AND SINGLE-SESSION DUCTAL CLEARANCE WAS ACHIEVED USING STANDARD TECHNIQUES IN 99.7% OVER MEDIAN DURATION OF 14 MIN (INTERQUARTILE RANGE [IQR] 9-21 MIN). OF 88 (21.5%) PATIENTS WITH DIFFICULT CBDS, TAPERED DUCT WAS SEEN IN 79 (89.8%) AND/OR STONE-DUCT MISMATCH IN 36 (40.9%). SINGLE-SESSION DUCTAL CLEARANCE WAS ACHIEVED IN ALL 88 PATIENTS (100%) BY LBS IN 79 (89.8%), MECHANICAL LITHOTRIPSY IN 20 (22.7%), AND SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LITHOTRIPSY IN 16 (18.2%) OVER A MEDIAN DURATION OF 29 MIN (IQR 17-47 MIN). OVERALL, SINGLE-SESSION DUCTAL CLEARANCE WAS ACHIEVED IN 99.8% WITH ADVERSE EVENTS IN 17 (4.2%) THAT INCLUDED PERFORATION IN TWO, POSTSPHINCTEROTOMY BLEEDING IN ONE, AND MILD/MODERATE POST-ERCP PANCREATITIS IN 14 PATIENTS. CONCLUSIONS: A PREDETERMINED PROTOCOL OPTIMIZED OUTCOMES BY ENABLING SINGLE-SESSION DUCTAL CLEARANCE OF CBDS WITH HIGH TECHNICAL SUCCESS AND LOW ADVERSE EVENTS. ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ 1. PERFORATION(N=2) 2. POST SPHINCTEROTOMY BLEEDING(N=1) 3. MILD/MODERATE POST-ERCP PANCREATITIS(N=14) ONE PATIENT WITH DUODENAL PERFORATION WAS SUCCESSFULLY TREATED WITH PLACEMENT OF AN OVER-THE-SCOPE CLIP, WHICH SEALED THE PERFORATION AND CONFIRMED ON FLUOROSCOPY. DURING HOSPITALIZATION POST PROCEDURE, THE PATIENT ASPIRATED CLEAR LIQUIDS, DEVELOPED ASPIRATION PNEUMONIA, AND SUBSEQUENTLY HAD A CARDIOPULMONARY ARREST. SUPPORTIVE CARE FROM THIS PATIENT WAS WITHDRAWN 7 DAYS AFTER INTERVENTION. ADMISSION WAS NEEDED POST-PROCEDURE TO THE TREATING FACILITY BECAUSE OF ACUTE PANCREATITIS, PERFORATION, ABDOMINAL PAIN, BLEEDING. DUODENAL PERFORATION WAS ENCOUNTERED IN TWO PATIENTS DURING DUODENOSCOPE NAVIGATION THAT WERE MANAGED ENDOSCOPICALLY USING OVER-THE-SCOPE CLIPS. A STENT WAS PLACED IN ONE PATIENT WHO UNDERWENT A SUCCESSFUL SECOND ERCP FOR STONE EXTRACTION. MILD AND MODERATE PANCREATITIS WERE ENCOUNTERED IN SIX AND THREE PATIENTS, RESPECTIVELY, WHO WERE MANAGED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351909 SINGLE USE 3-LUMEN EXTRACTION BALLOON V SINGLE USE 3-LUMEN EXTRACTION BALLOON FGE AOMORI OLYMPUS CO., LTD. B-V232P-A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H| R MECHANICAL LITHOTRIPTOR V BML-V232QR-30 SN-UNK