BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS CANNULA + PIK

    MDR report key: 20320023 · Received September 27, 2024

    Report

    Report Number
    8010762-2024-0000467
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 6, 2024
    Report Date
    November 12, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWF
    UDI-DI
    04037691519876
    PMA / PMN Number
    K131666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE BENT DETECTED AT THE TIP OF THE GUIDE WIRE. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. THE SAMPLE COULD NOT BE INVESTIGATED SINCE THE COMPLAINT GUIDEWIRE WAS DISCARDED BY CUSTOMER. HOWEVER, BASED ON THE PROVIDED PICTURE, FAILURE COULD BE CONFIRMED. BASED ON THE INVESTIGATION RESULTS, EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED FAILURE COULD BE LINKED TO THE RISK ASSESSMENT FILE OF THE PRODUCT AND POSSIBLE CAUSES ARE; USER: APPLICATION OF DAMAGED PRODUCT, USER ERROR: USER DOES NOT REMOVE THE PUNCTURE NEEDLE BEFORE THE GUIDEWIRE IS RETRACTED FOR REPOSITIONING, MANUFACTURING: MATERIALS, COMPONENTS OR DEVICE COMPROMISED DURING PRODUCTION, MATERIAL: USE OF UNQUALIFIED MATERIALS. THESE ROOT CAUSES COULD NOT BE CONFIRMED. HOWEVER, ACCORDING TO THE CORRESPONDING INCOMING INSPECTION REPORTS, ALL TESTS WERE PASSED AS PER SPECIFICATIONS. BASED ON THE PROVIDED THE MANUFACTURING DOCUMENTATION BY SUPPLIER, MATERIAL RELATED INFLUENCES ARE UNLIKELY. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED PIK 150#INSERTION KIT GUIDEWIRE 150 CM WITH LOT# 3000377477 WAS REVIEWED ON 2024-10-07. ACCORDING TO THE DHR RESULT, THE PRODUCT PIK 150#INSERTION KIT GUIDEWIRE 150 CM PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. FURTHER, THE INCOMING INSPECTION REPORT OF THE AFFECTED COMPONENT GUIDE WIRE (BATCH # 3000193483) WAS REVIEWED ON 2024-10-07. GETINGE MEDICAL AFFAIRS CONSULTED A MEDICAL EVALUATION, A QUESTIONNAIRE WAS SHARED WITH CUSTOMER AND AN EVALUATION WAS PERFORMED BY MEDICAL AFFAIRS BASED ON THE PROVIDED INFORMATION WITHIN THE COMPLAINT AND QUESTIONNAIRE. THE DATA PRESENTED HERE ARE DERIVED FROM THE CUSTOMER PRODUCT COMPLAINT SINGLE REPORT DATED (B)(6) 2024, AND THE CUSTOMER'S RESPONSES TO RELEVANT QUESTIONS. ACCORDING TO THE CUSTOMER, THE INCIDENT INVOLVED A PIK, WHICH EXHIBITED VISIBLE DAMAGE. IN RESPONSE TO THE FINAL QUESTION WHETHER THE AFFECTED GUIDEWIRE WAS USED THROUGHOUT THE ENTIRE CANNULA PLACEMENT PROCEDURE AND IN WHICH VESSEL IT WAS USED, THE CUSTOMER RESPONDED ¿NO, IT IS NOT SMOOTH TO INSERT THE GUIDEWIRE¿. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION REGARDING WHICH VESSEL(S) WERE AFFECTED OR WHETHER THESE EXHIBITED PATHOLOGIES SUCH AS CALCIFICATIONS. HOWEVER, THE CUSTOMER REPORTED THAT THE PACKAGING OR PRODUCT SHOWED NO DAMAGE UPON UNPACKING, LEADING TO THE ASSUMPTION THAT THE CREASE MIGHT HAVE BEEN OCCURRED DURING USE WHICH MAY BE SUPPORTED BY THE CUSTOMER¿S STATEMENT INDICATING THAT THE GUIDEWIRE COULD NOT BE INSERTED SMOOTHLY INTO THE VESSEL. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR THE PIK SET STATES THAT IT SHOULD BE ENSURED ¿[¿] THAT THE GUIDE WIRE CAN BE ADVANCED FREELY". THE CUSTOMER¿S REPORT THAT THE GUIDE WIRE WAS NOT ADVANCING SMOOTHLY MAY INDICATE THAT IT COULD NOT BE FREELY ADVANCED. WITH THE CURRENT INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHETHER THIS ISSUE WAS DUE TO THE PATIENT'S VESSEL CONDITION, THE USAGE METHOD, OR THE PRODUCT ITSELF. ADDITIONALLY, THERE IS NO LCE REPORT AVAILABLE, AS THE AFFECTED GUIDE WIRE WAS DISCARDED FOLLOWING USE. IN CONCLUSION, THE EVIDENCE PROVIDED NEITHER CONFIRMS NOR EXCLUDES A COMPONENT FAILURE OR MATERIAL WEAKNESS IN THE AFFECTED PIK. BASED ON THE AVAILABLE INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE REPORTED KINK IN THE GUIDEWIRE ASSOCIATED WITH THIS COMPLAINT. NEVERTHELESS, THE IFU SPECIFIES THAT THE GUIDE WIRE SHOULD BE ADVANCED FREELY AND SHOULD NOT BE POSITIONED WITH PRESSURE OR FORCE, WHICH ULTIMATELY MAY HAVE CONTRIBUTED TO THE DAMAGE OBSERVED IN THE AFFECTED PIK. 7 APPLICATION 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. FOLLOWING MITIGATIONS FROM INSTRUCTION FOR USE (IFU) OF PRODUCT WERE ALSO POINTED OUT: 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. INSERT THE J-TIP OF THE GUIDE WIRE THROUGH THE PUNCTURE NEEDLE AND INTO THE VESSEL. MAKE SURE THAT THE GUIDE WIRE CAN BE ADVANCED FREELY. IFU CAUTION! TO PREVENT THE GUIDE WIRE FROM BEING DAMAGED, DO NOT RETRACT IT WHILST THE PUNCTURE NEEDLE IS IN THE VESSEL. IF THE GUIDE WIRE HAS TO BE REMOVED AGAIN, FIRSTLY REMOVE THE PUNCTURE NEEDLE FROM THE VESSEL, AND THEN CAREFULLY REMOVE THE GUIDE WIRE. SINCE THE CORRESPONDING INCOMING INSPECTION REPORTS DOES NOT INDICATE ANY FAILURE RELATED TO THE MATERIAL, IT MUST BE ASSUMED THAT THE PRODUCT FUNCTIONED AS EXPECTED AND AS DESIGNED. BASED ON THE PROVIDED THE MANUFACTURING DOCUMENTATION BY SUPPLIER, MATERIAL INFLUENCE COULD BE EXCLUDED. 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 THE BENT DETECTED AT THE TIP OF THE GUIDE WIRE. FAILURE FOUND DURING TREATMENT. PRODUCT WAS REPLACED DUE TO SAFETY CONCERNS. NO HARM OR DEATH TO ANY PERSON WAS REPORTED. COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1663502 HLS CANNULA + PIK CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MAQUET CARDIOPULMONARY GMBH PIK 150#INSERTION KIT, GUIDEWIRE 150 CM 3000377477 04037691519876

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other