BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 15994982 · Received December 16, 2022

    Report

    Report Number
    1037905-2022-00678
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 12, 2021
    Report Date
    December 16, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510K: K172665. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. HOWEVER, A DEVICE FAILURE WAS NOT REPORTED IN THE ARTICLE. THE ARTICLE REPORTED OCCURRENCES OF HEMORRHAGES, PANCREATITIS, AND CHOLANGITIS. ALL ARE KNOWN COMPLICATION OF THESE TYPES OF PROCEDURES. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING POTENTIAL COMPLICATIONS: "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST." THE ARTICLE REFERENCES MODIFICATIONS MADE TO THE DEVICE. THE IFU WARNS: "NO MODIFICATION OF THIS EQUIPMENT IS ALLOWED." PRIOR TO DISTRIBUTION, ALL TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. DE LA MORENA MADRIGAL EMILIO J ET AL. "INITIAL EXPERIENCE WITH¿" ENDOSC INT OPEN 2021; 09: E1611¿E1616.

    Description of Event or Problem · 0

    A CLINICAL LITERATURE ARTICLE WAS PUBLISHED REGARDING COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOMES. BELOW ARE RELEVANT EXCERPTS: "THE HOME-MADE HYBRID TOME HT WAS CONSTRUCTED FROM THE INSULATED METAL CORE OF A HUIBREGTSE HPC-2 NKPT (COOK MEDICAL, BLOOMINGTON INDIANA, UNITED STATES), WHICH WAS INSERTED THROUGH THE GUIDE CHANNEL OF A CONVENTIONAL CT WITH A LUER CONNECTOR AT THE MOUTH OF THE CHANNEL. BECAUSE THE LENGTHS OF THE TWO DEVICES ARE NOT CONSISTENT, THE CHANNEL OF THE CT WAS EXTENDED BY USING ONE OR MORE SERIAL CONNECTORS UNTIL ONLY THE NEEDLE EMERGED FROM THE TIP WHEN THE HANDLE WAS IN THE EXTENDED POSITION...THE CT WE USED WERE CLEVER-CUT 3V (OLYMPUS, TOKYO, JAPAN) (OC-HT), TRUE-TOME 44 (BOSTON SCIENTIFIC, NATICK MASSACHUSETTS, UNITED STATES) (BSC-HT) AND TRI-TOME 30 (COOK MEDICAL, BLOOMINGTON INDIANA, UNITED STATES) (CC-HT) DEVICES... BETWEEN MAY 2016 AND APRIL 2020, WE PERFORMED 683 ERCP, OF WHICH 465 WERE ABLE TO BE ANALYZED. IN 48 CASES A TPP WAS PERFORMED AND IN 55 A NKP, OF WHICH 12 WERE CONDUCTED WITH A STANDARD NKPT AND 43 WITH AN HT. THIRTY-EIGHT OF THE 43 HT PROCEDURES WERE COMPLETED IN ONE STEP AND FIVE IN TWO STEPS. AS A RESULT, OUR FINAL STUDY GROUP COMPRISED 43 PATIENTS WHO UNDER WENT 48 ERCPS... IN 12 [PROCEDURES] WE USED THE CC HT... IN ALL THE PROCEDURES, EXCEPT FOR TWO PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), 100MG OF RECTAL INDOMETHACIN WAS ADMINISTERED. TWO PATIENTS AT HIGH RISK OF PAP RECEIVED HYPERHYDRATION WITH RINGER'S SOLUTION. NO PREVENTIVE PANCREATIC STENTS WERE IMPLANTED... WE RECORDED 11 AES (23 %): FIVE HEMORRHAGES, FOUR CASES OF PANCREATITIS (1 SEVERE), AND TWO CASES OF CHOLANGITIS. ALL OCCURRED AFTER THE FIRST STEP EXCEPT FOR ONE BLEED ATTRIBUTABLE TO THE TRACTION PAPILLOTOMY PERFORMED IN THE SECOND STEP. THE 100% TECHNICAL SUCCESS WAS MATCHED BY A 95% CLINICAL SUCCESS RATE (41 PATIENTS)..." THERE WERE A TOTAL OF 5 CASES OF HEMORRHAGES, 4 CASES OF PANCREATITIS, AND 2 CASES OF CHOLANGITIS. BOTH COOK HPC AND TRI DEVICES WERE INVOLVED. IT IS UNKNOWN WHICH OF THE AFOREMENTIONED ADVERSE EVENTS OCCURRED WITH EACH DEVICE. THEREFORE, THIS MDR CAPTURES THESE EVENTS FOR THE TRI. A SEPARATE MDR WILL BE SENT TO CAPTURE THESE EVENTS FOR THE HPC. NO INFORMATION PROVIDED REGARDING INTERVENTION; HOWEVER, INTERVENTION WOULD HAVE BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258312 TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention