BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS CANNULAE & PIK

    MDR report key: 19180867 · Received April 25, 2024

    Report

    Report Number
    8010762-2024-00229
    Event Type
    Death
    Date Received
    April 25, 2024
    Report Date
    June 26, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    PMA / PMN Number
    K102532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : 4115

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION WAS OBTAINED BY GETINGE SALES & SERVICE REPRESENTATIVE WHIIE GATHERING INFORMATION FOR COMPLAINT MCP REF. (B)(4) (MFG REPORT NUMBER 8010762-2024-00184). THE REPORTED FAILURE WAS OCCURRED ON THE SAME PATIENT AND DURING THE SAME EVENT WITH COMPLAINT MCP REF. (B)(4) (MFG REPORT NUMBER 8010762-2024-00184). IT WAS REPORTED THAT A BLOOD VESSEL WAS LACERATED WHEN A HLS CANNULAE INSERTED. THE CAUSE OF THE DAMAGE WAS REPORTED AS CANNULATION PROCEDURE COMPLICATIONS BY CUSTOMER. PATIENT EXPIRED DURING TREATMENT. MORE INFORMATION WAS REQUESTED FROM CUSTOMER TO EVALUATE THE FAILURE CLEARLY HOWEVER IT WAS CONFIRMED THAT THE FAILURE IS RELATED WITH USER FAILURE AND MORE INFORMATION WILL NOT BE PROVIDED. THE SAMPLE INVESTIGATION COULD NOT BE PERFORMED SINCE THE PRODUCT WAS DISCARDED BY CUSTOMER. HOWEVER, CUSTOMER REPORTED A SERIOUS INJURY / DEATH WITHIN THE COMPLAINT. BASED ON THIS, COMPLAINT COULD BE CONFIRMED BUT PRODUCT FAILURE COULD NOT BE CONFIRMED. THE LOT NUMBER OF THE PRODUCT COULD NOT BE PROVIDED BY CUSTOMER. THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. FURTHER, THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED COMPONENTS WITH RELATED TO THE REPORTED FAILURE. GETINGE MEDICAL AFFAIRS CONDUCTED A MEDICAL REVIEW. THE REPORTED FAILURE WAS DESCRIBED AS: THE COMPLAINT NARRATIVE THAT PERTAINS TO BOTH COMPLAINT #1016449 AND #1016710 DETAIL AN INCIDENT WHERE THE GUIDEWIRE USED FOR CANNULA INSERTION BECAME KINKED UPON ENTRY INTO THE BODY. ADDITIONALLY, IT IS NOTED THAT RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE GUIDEWIRE, WHICH WAS FOUND TO BE BROKEN BEFORE THE CANNULA WAS INSERTED. WHILE INSERTION OF THE CANNULA THE AFFECTED BLOOD VESSEL WAS TORN. THE FACILITY REPORTED THAT COMPLICATIONS FROM THE CANNULATION PROCEDURE, A VESSEL LACERATION DURING CANNULA INSERTION, WERE RESPONSIBLE FOR THE PATIENT'S DETERIORATION, AND THEREFORE, THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE BROKEN GUIDEWIRE AND THE DEMISE OF THE PATIENT. AS A CONCLUSION OF MEDICAL REVIEW: A DEFINITIVE CAUSE OF THE INCIDENT CANNOT BE PROPERLY EVALUATED WITHOUT FURTHER INFORMATION OR THE PRESENCE OF THE SUSPECTED/REPORTED GUIDEWIRE. THE VESSEL TORN/LACERATION DURING THE PLACEMENT OF CANNULA WAS REPORTED BY CUSTOMER WHICH MIGHT HAVE CAUSED TO PATIENT¿S EXPIRATION. SINCE THE GUIDEWIRE BECAME KINKED, WAS STUCK, AND BROKEN DURING PLACEMENT, THE DAMAGE OF THE VESSEL COULD BE CAUSED BY A PLACEMENT TECHNIQUE OR PRE-EXISTING CONDITIONS OF THE VESSEL. THE RELATED MITIGATIONS ARE IN PLACE ACCORDING TO THE INSTRUCTION FOR USE OF THE PRODUCT (PIK) AS FOLLOW: 4 CONTRAINDICATIONS THE DEVICE MUST NOT BE USED IN THE FOLLOWING CONDITIONS: KNOWN DISSECTION OF THE TARGET VESSEL. SEVERE PERIPHERAL VASCULAR DISEASE, INCLUDING SEVERE VESSEL CALCIFICATION. PRESENCE OF VASCULAR GRAFTS OR AN INTRAVASCULAR STENT AT THE INTENDED CANNULATION SIZE. KNOWN MISMATCH BETWEEN VESSEL DIAMETER AND INTENDED CANNULA SIZE. KNOWN PARTIAL OR TOTAL OCCLUSION OF THE TARGET VESSEL. GIVEN THAT THE DEVICE IS USED IN ACCORDANCE WITH THE STATED OPERATING CONDITIONS AND WITHIN THE SCOPE OF THE INTENDED USE, NO ADDITIONAL CONTRAINDICATIONS ARE KNOWN. IFU WARNING! DAMAGE TO THE DEVICE OR PACKAGING. A NON-STERILE OR DEFECTIVE DEVICE CAN LEAD TO BLOOD LOSS OR TO EMBOLISMS OR INFECTIONS IN THE PATIENT. 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 FRACTURES. ONLY USE A STERILIZED DEVICE. DO NOT USE THE DEVICE IF THE DEVICE ITSELF OR THE STERILE PACKAGING SHOW ANY SIGNS OF DAMAGE. OBSERVE THE USE-BY DATE ON THE PACKAGING. ADHERE TO STRICT ASEPSIS WHEN USING THE DEVICE. IFU WARNING! IN ORDER TO MINIMIZE THE RISK OF TISSUE DAMAGE, ONLY INSERT THE GUIDE WIRE WITH THE J-TIP AHEAD. IFU CAUTION! VERIFY THE ADVANCEMENT AND POSITIONING OF THE GUIDE WIRE USING APPROPRIATE IMAGING TECHNOLOGY. IFU WARNING! THE POSITION OF THE GUIDEWIRE MUST NOT BE ALTERED WHILE INSERTING THE CANNULA. THE DETAILS PROVIDED BY THE CORRESPONDENCE IN ADDITION TO THE COMPLAINT NARRATIVE PROVIDE COMMENTARY THAT THE GUIDEWIRE WAS KINKED BEFORE INSERTION OF THE CANNULA AND, SEEMINGLY, FRACTURED SOMETIME AFTER CANNULATION. IT IS UNCLEAR IF A CHAIN OF EVENTS WAS PLACED IN ACTION AT THE TIME OF GUIDEWIRE PLACEMENT WHEN THE WIRE WAS INITIALLY KINKED. CONSEQUENTLY, IT IS CHALLENGING TO ASSIGN A DEFINITIVE CAUSE OF THE INCIDENT (GIVEN THE AVAILABLE EVIDENCE) TO A DEFECT IN EITHER THE GUIDEWIRE OR TO THE CANNULA. FINALLY, IT IS DIFFICULT TO CONFLATE THE EXPIRATION OF THE PATIENT TO A MALFUNCTION OR MALPERFORMANCE OF THE GUIDEWIRE OR CANNULA AS LIMITED INFORMATION IS KNOWN ABOUT THE EVENT ITSELF, THE ACTIVITIES SURROUNDING THE REPORTED EVENT OR THE PATIENTS¿ COMORBIDITIES. 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. H3 OTHER TEXT : 4115.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS OBTAINED BY GETINGE SALES & SERVICE REPRESENTATIVE "WHILE" GATHERING INFORMATION FOR COMPLAINT MCP REF. (B)(4) (MFG REPORT NUMBER 8010762-2024-00184). THE REPORTED FAILURE WAS OCCURRED ON THE SAME PATIENT AND DURING THE SAME EVENT WITH COMPLAINT MCP REF. (B)(4) (MFG REPORT NUMBER 8010762-2024-00184). IT WAS REPORTED THAT A BLOOD VESSEL WAS LACERATED WHEN A HLS CANNULAE INSERTED. THE CAUSE OF THE DAMAGE WAS REPORTED AS CANNULATION PROCEDURE COMPLICATIONS BY CUSTOMER. PATIENT EXPIRED DURING TREATMENT. COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145910 HLS CANNULAE & PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death