BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET

    MDR report key: 20843219 · Received December 4, 2024

    Report

    Report Number
    2522007-2024-00041
    Event Type
    Death
    Date Received
    December 4, 2024
    Date of Event
    November 21, 2024
    Report Date
    January 13, 2025
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    GCC
    UDI-DI
    00827002198609
    PMA / PMN Number
    K893480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS KNOWN. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS KNOWN. E3 - OCCUPATION: DOCTOR. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "PATIENT DIED AFTER PERFORATION OF THE CARDIA APEX AND CONVERSION TO OPEN CHEST SURGERY." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO SIGNS THAT THE DEVICE WAS NONCONFORMING OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN THE COMPLAINT SUMMARY TAB OF TRACKWISE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ON 25NOV2024, PHILIPS JAPAN PROVIDED THE FOLLOWING INFORMATION REGARDING ADVERSE EVENTS OCCURRING DURING LEAD REMOVAL CASES. DEVICES USED: LR-PPLBES-10.0 (N204846) LR-PPLBES-11.5 (N201075) PHILIPS/GLIDELIGHT 14FR PHILIPS/GLIDELIGHT 16FR THIS WAS A LEAD EXTRACTION PROCEDURE FOR INFECTION. RV LEAD EXTRACTION WAS PROCEEDED USING A PHILIPS/GLIDELIGHT 14FR, A BYRD 10F (LR-PPLBES-10.0), AND A BYRD 11.5F (LR-PPLBES-11.5). PHILIPS/GLIDELIGHT 14FR AND THE OUTER HAD BEEN ADVANCED FROM NEAR THE TRICUSPID VALVE, BUT THE OUTER DID NOT ADVANCE PROPERLY A FEW CENTIMETERS BEFORE THE TIP OF THE LEAD, SO GLIDELIGHT 14FR WAS CHANGED TO A GLIDELIGHT 16FR. THE GLIDELIGHT 16FR WAS ADVANCED, AND THE LASER WAS IRRADIATED FOR 1 SECOND A FEW CENTIMETERS BEFORE THE TIP OF THE LEAD. THE GLIDELIGHT 16FR WAS REMOVED WITHOUT FURTHER LASER IRRADIATION, BUT AT THE MOMENT OF REMOVAL, FLUOROSCOPY SHOWED THAT THE GLIDELIGHT HAD ADVANCED SEVERAL CM TOWARD THE CARDIAC APEX. IMMEDIATELY AFTER REMOVAL OF THE GLIDELIGHT 16FR, PERICARDIAL EFFUSION AND A DROP IN BLOOD PRESSURE WERE CONFIRMED. THE CARDIOVASCULAR SURGERY DEPARTMENT WAS CONTACTED, AND EMERGENCY ECMO, THORACOTOMY, AND RIGHT VENTRICULAR REPAIR WERE PERFORMED. THE GLIDELIGHT PROTRUDED SEVERAL CENTIMETERS FROM THE CARDIAC APEX. ALTHOUGH THE RA LEAD HAD NOT BEEN COMPLETELY REMOVED, IT HAD ALREADY DETACHED FROM THE ATRIAL WALL DURING THE REPAIR SURGERY, AND IT WAS DECIDED THAT IT COULD BE EASILY REMOVED ONCE THE REPAIR HAD SETTLED, SO REMOVAL WAS SCHEDULED TO BE PERFORMED PENDING THE REPAIR. ON 27NOV2024: THE FOLLOWING INFORMATION WAS ADDED BY THE SALES REP. PATIENT ANATOMY BEFORE SURGERY AND AT THE TIME OF FAILURE: PACEMAKER LEAD HAD BEEN IMPLANTED FROM LEFT CHEST TO RIGHT ATRIUM AND RIGHT VENTRICLE RESPECTIVELY. PRIMARY DISEASE: INFECTION THE RIGHT VENTRICLE WAS APPROACHED VIA THE LEFT SUBCLAVIAN VEIN FOR LEAD EXTRACTION. THE USER STARTED WITH A PHILIPS/GLIDELIGHT 14FR AND CONTINUED TO USE IT UP TO THE TRICUSPID VALVE, AND USED A PPLBES 10FR AND A PPLBES 11.5FR IN AREAS WHERE THE GLIDELIGHT 14FR COULD NOT ADVANCE. THE REASON FOR USING TWO SIZES OF PPLBES WAS THAT A 10FR WAS FIRST USED, AND THEN A LARGER SIZE WAS USED AFTER IT WAS DETERMINED THAT THERE WAS SIGNIFICANT ADHESION. THE USER USED PPLBES UP UNTIL SVC, THEN SWITCHED BACK TO GLIDELIGHT 14FR. HOWEVER, IT DID NOT ADVANCE AT THE TRICUSPID VALVE, SO IT WAS CHANGED TO A PHILIPS/GLIDELIGHT 16FR. THERE WAS STRONG ADHESION AT THE CARDIAC APEX, SO THE USER USED THE LASER TO PERFORM COUNTERTRACTION (KEEPING THE SHEATH IN PLACE AND PULLING THE LEAD), AND THE BLOOD PRESSURE DROPPED. PCPS WAS ADMINISTERED AND THEN THORACOTOMY WAS PERFORMED. <SALES REP'S COMMENT> THE RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND COOK PRODUCTS CANNOT BE CONFIRMED (IS UNKNOWN). IT SEEMS THE PATIENT HAD AN INFECTION AND IT WAS NECESSARY TO REMOVE THE LEAD COMPLETELY. THE PATIENT EXPERIENCED RIGHT VENTRICULAR PERFORATION WITH A GLIDELIGHT 16FR, CARDIAC TAMPONADE, AND THE PATIENT WAS OPERATED ON TO SURGICALLY REPAIR THE AFFECTED AREA, BUT DIED IN THE END. HOWEVER, IT IS UNCLEAR WHETHER THE DIRECT CAUSE OF THE PATIENT'S DEATH WAS THE RIGHT VENTRICULAR PERFORATION. ON 28NOV2024: THE FOLLOWING INFORMATION WAS ADDED BY THE SALES REP. ACCORDING TO OUR SALES REP, A PHILIPS REPRESENTATIVE WHO WAS PRESENT DURING THE SURGERY CONFIRMED THAT THE GLIDELIGHT 16FR HAD CLEARLY PROTRUDED FROM THE RV (RIGHT VENTRICLE) WHEN THE CHEST WAS OPENED. AT THAT POINT, THE PHILIPS REPRESENTATIVE REPORTEDLY DECIDED THAT HE COULD NOT BE PRESENT ANY LONGER AND LEFT THE SITE. OUR SALES REPRESENTATIVE ATTEMPTED TO CONFIRM THE CIRCUMSTANCES LEADING UP TO THE PATIENT'S DEATH AND THE CAUSAL RELATIONSHIP/CONNECTION OF THE COOK PRODUCT TO WHAT THE PHYSICIAN BELIEVED WAS THE CAUSE OF DEATH, BUT WAS UNABLE TO OBTAIN ANY INFORMATION FROM THE FACILITY (PHILIPS APPARENTLY DID NOT HAVE THIS INFORMATION EITHER, AND WAS UNABLE TO OBTAIN ANY INFORMATION FROM PHILIPS EITHER).

    Description of Event or Problem · 0

    ON 25NOV2024, PHILIPS JAPAN PROVIDED THE FOLLOWING INFORMATION REGARDING ADVERSE EVENTS OCCURRING DURING LEAD REMOVAL CASES. DEVICES USED: LR-PPLBES-10.0 (LOT UNKNOWN). LR-PPLBES-11.5 (LOT UNKNOWN). PHILIPS/GLIDELIGHT 14FR. PHILIPS/GLIDELIGHT 16FR. THIS WAS A LEAD EXTRACTION PROCEDURE FOR INFECTION. RV LEAD EXTRACTION WAS PROCEEDED USING A PHILIPS/GLIDELIGHT 14FR, A BYRD 10F (LR-PPLBES-10.0), AND A BYRD 11.5F (LR-PPLBES-11.5). PHILIPS/GLIDELIGHT 14FR AND THE OUTER HAD BEEN ADVANCED FROM NEAR THE TRICUSPID VALVE, BUT THE OUTER DID NOT ADVANCE PROPERLY A FEW CENTIMETERS BEFORE THE TIP OF THE LEAD, SO GLIDELIGHT 14FR WAS CHANGED TO A GLIDELIGHT 16FR. THE GLIDELIGHT 16FR WAS ADVANCED, AND THE LASER WAS IRRADIATED FOR 1 SECOND A FEW CENTIMETERS BEFORE THE TIP OF THE LEAD. THE GLIDELIGHT 16FR WAS REMOVED WITHOUT FURTHER LASER IRRADIATION, BUT AT THE MOMENT OF REMOVAL, FLUOROSCOPY SHOWED THAT THE GLIDELIGHT HAD ADVANCED SEVERAL CM TOWARD THE CARDIAC APEX. IMMEDIATELY AFTER REMOVAL OF THE GLIDELIGHT 16FR, PERICARDIAL EFFUSION AND A DROP IN BLOOD PRESSURE WERE CONFIRMED. THE CARDIOVASCULAR SURGERY DEPARTMENT WAS CONTACTED, AND EMERGENCY ECMO, THORACOTOMY, AND RIGHT VENTRICULAR REPAIR WERE PERFORMED. THE GLIDELIGHT PROTRUDED SEVERAL CENTIMETERS FROM THE CARDIAC APEX. ALTHOUGH THE RA LEAD HAD NOT BEEN COMPLETELY REMOVED, IT HAD ALREADY DETACHED FROM THE ATRIAL WALL DURING THE REPAIR SURGERY, AND IT WAS DECIDED THAT IT COULD BE EASILY REMOVED ONCE THE REPAIR HAD SETTLED, SO REMOVAL WAS SCHEDULED TO BE PERFORMED PENDING THE REPAIR. ON 27NOV2024: THE FOLLOWING INFORMATION WAS ADDED BY THE SALES REP. PATIENT ANATOMY BEFORE SURGERY AND AT THE TIME OF FAILURE: PACEMAKER LEAD HAD BEEN IMPLANTED FROM LEFT CHEST TO RIGHT ATRIUM AND RIGHT VENTRICLE RESPECTIVELY. PRIMARY DISEASE: INFECTION THE RIGHT VENTRICLE WAS APPROACHED VIA THE LEFT SUBCLAVIAN VEIN FOR LEAD EXTRACTION. THE USER STARTED WITH A PHILIPS/GLIDELIGHT 14FR AND CONTINUED TO USE IT UP TO THE TRICUSPID VALVE, AND USED A PPLBES 10FR AND A PPLBES 11.5FR IN AREAS WHERE THE GLIDELIGHT 14FR COULD NOT ADVANCE. THE REASON FOR USING TWO SIZES OF PPLBES WAS THAT A 10FR WAS FIRST USED, AND THEN A LARGER SIZE WAS USED AFTER IT WAS DETERMINED THAT THERE WAS SIGNIFICANT ADHESION. THE USER USED PPLBES UP UNTIL SVC, THEN SWITCHED BACK TO GLIDELIGHT 14FR. HOWEVER, IT DID NOT ADVANCE AT THE TRICUSPID VALVE, SO IT WAS CHANGED TO A PHILIPS/GLIDELIGHT 16FR. THERE WAS STRONG ADHESION AT THE CARDIAC APEX, SO THE USER USED THE LASER TO PERFORM COUNTERTRACTION (KEEPING THE SHEATH IN PLACE AND PULLING THE LEAD), AND THE BLOOD PRESSURE DROPPED. PCPS WAS ADMINISTERED AND THEN THORACOTOMY WAS PERFORMED. <SALES REP'S COMMENT> THE RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND COOK PRODUCTS CANNOT BE CONFIRMED (IS UNKNOWN). IT SEEMS THE PATIENT HAD AN INFECTION AND IT WAS NECESSARY TO REMOVE THE LEAD COMPLETELY. THE PATIENT EXPERIENCED RIGHT VENTRICULAR PERFORATION WITH A GLIDELIGHT 16FR, CARDIAC TAMPONADE, AND THE PATIENT WAS OPERATED ON TO SURGICALLY REPAIR THE AFFECTED AREA, BUT DIED IN THE END. HOWEVER, IT IS UNCLEAR WHETHER THE DIRECT CAUSE OF THE PATIENT'S DEATH WAS THE RIGHT VENTRICULAR PERFORATION. ON 28NOV2024: THE FOLLOWING INFORMATION WAS ADDED BY THE SALES REP. ACCORDING TO OUR SALES REP, A PHILIPS REPRESENTATIVE WHO WAS PRESENT DURING THE SURGERY CONFIRMED THAT THE GLIDELIGHT 16FR HAD CLEARLY PROTRUDED FROM THE RV (RIGHT VENTRICLE) WHEN THE CHEST WAS OPENED. AT THAT POINT, THE PHILIPS REPRESENTATIVE REPORTEDLY DECIDED THAT HE COULD NOT BE PRESENT ANY LONGER AND LEFT THE SITE. OUR SALES REPRESENTATIVE ATTEMPTED TO CONFIRM THE CIRCUMSTANCES LEADING UP TO THE PATIENT'S DEATH AND THE CAUSAL RELATIONSHIP/CONNECTION OF THE COOK PRODUCT TO WHAT THE PHYSICIAN BELIEVED WAS THE CAUSE OF DEATH, BUT WAS UNABLE TO OBTAIN ANY INFORMATION FROM THE FACILITY (PHILIPS APPARENTLY DID NOT HAVE THIS INFORMATION EITHER, AND WAS UNABLE TO OBTAIN ANY INFORMATION FROM PHILIPS EITHER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977098 LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET GCC DILATOR, CATHETER GCC COOK VANDERGRIFT INC G19860 N201075 00827002198609

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Other| D LR-PPLBES-10.0.| LR-PPLBES-10.0.| PHILIPS/GLIDELIGHT 14FR.| PHILIPS/GLIDELIGHT 14FR.| PHILIPS/GLIDELIGHT 16FR.| PHILIPS/GLIDELIGHT 16FR.