BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 8198130 · Received December 26, 2018

    Report

    Report Number
    0002090040-2018-00018
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    November 14, 2018
    Report Date
    December 4, 2020
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLH
    UDI-DI
    00885825006884
    PMA / PMN Number
    K052603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11/18/2020, STRYKER SUSTAINABILITY SOLUTIONS BECAME AWARE THAT MDR SECTION B2. (OUTCOMES ATTRIBUTED TO AE) WAS NOT COMPLETED FOR THIS MDR. THIS SUPPLEMENTAL MDR SERVES TO PROVIDE THIS INFORMATION. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ABLATION FOR ATRIAL FIBRILLATION, THE DOCTOR OBSERVED A DROP IN THE PATIENT'S BLOOD PRESSURE. AFTER CHECKING ON INTRACARDIAC ECHO, THE DOCTOR NOTED A SMALL PERICARDIAL EFFUSION. HE STATED THAT HE BELIEVED THE EFFUSION WAS DUE TO A PERFORATION IN THE CORONARY SINUS WHEN HE HAD PLACED A CATHETER THERE EARLIER IN THE CASE (STRYKER LIVEWIRE). THE PHYSICIAN PROCEEDED WITH THE CASE AND COMPLETED THE PROCEDURE, LEAVING THE CORONARY SINUS CATHETER IN PLACE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED. AS THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS, EVALUATION WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR FOR THE REPORTED LOT NUMBER SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: USER IMPROPERLY MANIPULATES CATHETER AND/OR GUIDING SHEATH. ELECTRODE DAMAGE CAUSED BY MISHANDLING/IMPROPER STORAGE. POOR FIT OF COMPONENTS OR COMPONENT DAMAGE CAUSES USER TO EXERT EXCESSIVE FORCE INSERTING DEVICE (E.G. KINKS, BENDS, ELECTRODE DAMAGE, CUTS). THE INSTRUCTIONS FOR USE (IFU) STATE: INSPECT THE CATHETER FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE CATHETER IF ELECTRODES APPEAR LOOSE OR IF ANY DAMAGE IS NOTED. IF SUCH PROBLEMS EXIST, RETURN THE CATHETER AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS. CONNECT THE CATHETER TO THE CORRESPONDING CABLE CONNECTOR. CONNECT THE CABLE TO THE CORRECT ELECTRONIC EQUIPMENT FOR RECORDING AND/OR SENSING. OBSERVE POLARITY OF PROXIMALLY LOCATED CONNECTOR PINS OF THE INTERFACE CABLE WHEN CONNECTING TO THE ELECTRONIC EQUIPMENT. ISOLATE ANY UNUSED CONNECTOR PINS TO REDUCE DEVELOPMENT OF ACCIDENTAL CURRENT PATHWAYS TO THE HEART. FOLLOW A SUITABLE ELECTROPHYSIOLOGY STUDY PROTOCOL. DO NOT AUTOCLAVE CATHETER. DO NOT USE FOR ELECTRICAL ABLATION. AVOID EXCESSIVE CONTACT OF HANDPIECE WITH FLUIDS, AS THIS COULD ADVERSELY AFFECT THE ELECTRICAL PERFORMANCE OF THE CATHETER. DIAGNOSTIC EP CATHETERS ARE NOT RECOMMENDED FOR LONG TERM PACING. INSPECT THE PACKAGING AND CATHETER FOR DAMAGE OR DEFECTS PRIOR TO USE. THE REPORTED EVENT WILL BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ABLATION FOR ATRIAL FIBRILLATION, THE DOCTOR OBSERVED A DROP IN THE PATIENT'S BLOOD PRESSURE. AFTER CHECKING ON INTRACARDIAC ECHO, THE DOCTOR NOTED A SMALL PERICARDIAL EFFUSION. HE STATED THAT HE BELIEVED THE EFFUSION WAS DUE TO A PERFORATION IN THE CORONARY SINUS WHEN HE HAD PLACED A CATHETER THERE EARLIER IN THE CASE (STRYKER LIVEWIRE). THE PHYSICIAN PROCEEDED WITH THE CASE AND COMPLETED THE PROCEDURE, LEAVING THE CORONARY SINUS CATHETER IN PLACE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034659 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 401582 3515632 00885825006884

    Patients

    Seq Age Sex Outcome Treatment
    1 Other