BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 23377820 · Received October 24, 2025

    Report

    Report Number
    8010762-2025-0000471
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 15, 2025
    Report Date
    January 7, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691730677
    PMA / PMN Number
    K131666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING THE CANNULATION PROCESS, THE WIRE BROKE. THEN, CUSTOMER OPENED ANOTHER BOX FROM THE SAME BATCH TO CONTINUE TO PROCEDURE, HOWEVER THAT ONE WAS ALSO BROKE. NO HARM TO ANY PERSON WAS REPORTED. THE PRODUCT WAS INVESTIGATED AT MAQUET CARDIOPULMONARY GMBH LABORATORY ON 2025-12-24. VISUAL INSPECTION OF THE GUIDEWIRE SHOWS THAT THE OUTER WIRE IS ELONGATED AS IF A MECHANICAL TENSION FORCE WAS APPLIED. FROM THE CUSTOMER DESCRIPTION IT WAS REPORTED THAT THE ONE OF THE GUIDEWIRE BROKE DURING OPERATION AND THE OTHER ONE WAS FOUND BROKEN HOWEVER AFTER TAKING OUT FROM THE DISPENSER. SINCE THE PRODUCT INVESTIGATION SHOWS AN ELONGATION (DUE TO THE WIDELY SPIRALED WIRE) IT IS ASSUMED THAT THERE WAS A BLOCKAGE (IN A DILATOR OR THE NEEDLE (WHILE RETRACTION)) AND / OR FORCE WAS APPLIED. THIS OCCURRED IN APPLICATION THAT IS WHY A USER ERROR IS ASSUMED SINCE THE IFU STATES A COMPLETE EXTRACTION IN CASE OF A BLOCKAGE AND NO MECHANICAL PULL OUT. ADDITIONALLY, ONLY ONE GUIDEWIRE WAS ISSUED/SEND BACK TO THE COMPLAINT LAB, THIS CONCLUSION ONLY HANDLES THE COMPLAINT PRODUCT ON HAND. BASED ON THE INVESTIGATION RESULTS, COMPLAINT COULD BE CONFIRMED HOWEVER PRODUCT RELATED INFLUENCES COULD NOT BE CONFIRMED. THE MOST PROBABLE CAUSE WAS FOUND AS APPLIED MECHANICAL FORCE. FURTHER, THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED PIK 150-USA#INSERTION KIT GUIDEWIRE 150 WITH LOT#: 3000476322 WAS REVIEWED ON 2025-10-31. ACCORDING TO THE DHR RESULTS, THE PRODUCT PIK 150-USA#INSERTION KIT GUIDEWIRE 150 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS, PRODUCTION RELATED INFLUENCES ARE UNLIKELY. INCOMING INSPECTION REPORT OF THE RELATED GUIDEWIRE WAS ALSO CHECKED AND THERE COULD NOT BE DETECTED ANY NON-CONFORMITIES THAT COULD CAUSE TO REPORTED FAILURE. BESIDES, THE REPORTED FAILURE IS COVERED IN BASIC OPERATION PROCEDURE ASSEMBLING GUIDEWIRE DISPENSER: 5.1 VISUAL ASSESSMENT - PERFORM 100% VISUAL INSPECTION FOR GUIDEWIRE DISPENSER TUBE AND GUIDEWIRE. IF REQUIREMENTS ARE MET WITH THE ACCEPTANCE CRITERIA CONTINUE GUIDEWIRE DISPENSER PRODUCTION AND ASSEMBLY. CAUTION: ALL VISUAL ASSESSMENTS SHALL BE DONE UNDER A MINIMUM 2.5X MAGNIFICATION FOR GUIDEWIRE. %100 VISUAL ASSESSMENT; THERE SHALL BE NO BURRS ON THE GUIDEWIRE ADVANCER AND GUIDEWIRE DISPENSER. THERE SHALL BE NO KINK ON GUIDEWIRE AND GUIDEWIRE DISPENSER. THERE SHALL BE NO CRIMPS IN THE TIP AREA OF THE GUIDEWIRE. THERE SHALL BE NO OPENNESS BETWEEN THE WIRES. BASED ON THE INVESTIGATED GUIDEWIRE AND WITH THE ABOVE EXPLAINED VISUAL CONTROLS, IT IS NOT EVEN POSSIBLE TO COMPLETE PACKAGING OF IT WITH THIS KIND OF DAMAGE. THE REVIEW OF SCRAP, REWORK, ENHANCEMENTS AND DESIGN CHANGES WERE REVIEWED AN NO ABNORMALITIES IN REGARD TO THE REPORTED FAILURE WERE FOUND. IN ADDITION, A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. THE REVIEW OF THE NON-CONFORMITIES DOES NOT SHOW ANY NON-CONFORMITY IN REGARDS TO THE REPORTED FAILURE. BASED ON THESE INVESTIGATION RESULTS & CONTROL POINTS, MATERIAL RELATED INFLUENCES WERE FOUND AS "NOT LIKELY". A REVIEW OF THE CUSTOMER COMPLAINTS DID NOT SHOW A COMPLAINT RECORD THAT HAS A SAME IDENTICAL FAILURE. THE REVIEW SHOWS SPIKE AND KINK / BENT FAILURES HOWEVER WITHIN THIS SPECIFIC COMPLAINT, NEARLY HALF OF THE BODY OF THE GUIDEWIRE IS DAMAGED AND WIRES WERE SEPARATED WHICH CLUES AN EXTERNAL MECHANICAL FORCE. IFU, PERCUTANEOUS INSERTION KIT (PIK): THE USE OF NON-STERILE OR DEFECTIVE DEVICES CAN RESULT IN INFECTION OF THE PATIENT, USER AND THIRD PARTIES. ONLY USE THE DEVICE IF IT IS STERILE. DO NOT USE THE DEVICE IF IT OR THE STERILE PACKAGING IS DAMAGED. OBSERVE THE USE-BY DATE ON THE PACKAGING. ALWAYS OBSERVE STRICT ASEPSIS WHEN HANDLING THE DEVICE. IFU, PERCUTANEOUS INSERTION KIT (PIK): WARNING! DAMAGE TO THE DEVICE OR PACKAGING. A NON-STERILE OR DEFECTIVE DEVICE CAN RESULT IN PATIENT INFECTIONS. PERFORM A CAREFUL VISUAL INSPECTION OF THE STERILE PACKAGING BEFORE USE. PAY PARTICULAR ATTENTION TO MOISTURE, OPENINGS AND SOILING. PERFORM A CAREFUL VISUAL INSPECTION OF THE DEVICE BEFORE USE. IN PARTICULAR, ENSURE THERE IS NO DAMAGE TO THE MATERIAL, CRACKS, BURRS OR FISSURES. CHECK THE INTEGRITY OF THE DEVICES BEFORE USING THEM. IF YOU USE THE INSERTION AID FOR THE GUIDE WIRE, INSERT IT INTO THE LUER LOCK CONNECTION OF THE PUNCTURE NEEDLE AND ADVANCE THE GUIDE WIRE SLOWLY WITH YOUR THUMB. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE CANNULATION PROCESS, THE WIRE BROKE. THEN, CUSTOMER OPENED ANOTHER BOX FROM THE SAME BATCH TO CONTINUE TO PROCEDURE, HOWEVER THAT ONE WAS ALSO BROKE. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE EVENT HAD OCCURRED DURING TREATMENT / ON PATIENT USE AND THE PRODUCT CHANGE WAS REQUIRED, THE COMPLAINT IS REPORTABLE. COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504824 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH PIK 150-USA 3000476322 04037691730677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other