BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 9979887 · Received April 20, 2020

    Report

    Report Number
    0001056128-2020-00027
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    November 20, 2019
    Report Date
    March 15, 2022
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    NLH
    UDI-DI
    00885825009557
    PMA / PMN Number
    K112232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    'FDA REGISTRATION NUMBER' FIELD WAS INADVERTENTLY SELECTED AS MANUFACTURING SITE 0001056128 WITHIN THE INITIAL MDR. THE APPROPRIATE FDA REGISTRATION NUMBER FOR THE PHOENIX MANUFACTURING SITE IS 0002090040. THIS NARRATIVE DEMONSTRATES THIS UPDATE. THIS CORRECTION DOES NOT CHANGE THE MDR REPORTABILITY STATUS. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    UPDATES TO: G1, G3, G6, H2, H6 AND H10. ON NOVEMBER 1ST, 2017, STRYKER SUSTAINABILITY SOLUTIONS (SSS) RECEIVED A COMPLAINT FOR A DEFLECTABLE EP CATHETER. THE COMPLAINT DEVICE WAS RETURNED TO SSS FOR INVESTIGATION AND THE INVESTIGATION WAS COMPLETED ON NOVEMBER 30, 2017. MALFUNCTION MDRS HAVE BEEN FILED FOR SUBSEQUENT COMPLAINTS IN WHICH EP CATHETERS WERE CONFIRMED TO HAVE A KINK DISTAL TO THE TRANSITION POINT. IF THE DEVICE WAS NOT RETURNED BUT WAS ALLEGED TO HAVE A KINK DISTAL TO THE TRANSITION POINT, A MALFUNCTION MDR WAS ALSO FILED. AFTER FURTHER ANALYSIS OF THE REPORTED EVENT, THE DECISION WAS MADE TO DISCONTINUE FILING MDRS FOR EP CATHETER KINKS DISTAL TO THE TRANSITION POINT FOR THE FOLLOWING REASONS: ¿ THERE HAVE BEEN NO ADDITIONAL SERIOUS INJURIES REPORTED SINCE THE INITIATING MDR FILED ON DECEMBER 1, 2017. ¿ THE MOST LIKELY ROOT CAUSE OF THIS MALFUNCTION IS MISHANDLING OF THE DEVICE SUBSEQUENT TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU), CLEARLY ADVISE USERS TO AVOID USING EXCESSIVE PRESSURE DURING PLACEMENT OF CATHETER IF UNKNOWN RESISTANCE IS ENCOUNTERED OR TO AVOID USING EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER. IFUS CAN BE DOWNLOADED AT HTTP://SUSTAINABILITY.STRYKER.COM/IFU. ¿ THE OCCURRENCE RATE OF THE MALFUNCTION IS LOW AT 0.005% (25 MALFUNCTIONS / 469917 DEVICES SHIPPED BETWEEN THE DATE RANGE OF DECEMBER 1, 2017 ¿ APRIL 22, 2020). ¿ EACH CUSTOMER COMMUNICATION LETTER RECOMMENDS THAT PRODUCT IFUS BE PRINTED, REVIEWED, AND READILY AVAILABLE FOR OPERATOR REFERENCE DURING PROCEDURES WHEN USING OUR DEVICES. BASED ON THE ANALYSIS OF ADDITIONAL DATA IT WAS DETERMINED THAT THIS MALFUNCTION IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD THE MALFUNCTION RECUR. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED A CATHETER HAD AN INCORRECT CURVE. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED A CATHETER HAD AN INCORRECT CURVE. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. VISUAL INSPECTION REVEALED A KINK 6 CM FROM THE DISTAL TIP, DISTAL TO THE TRANSITION POINT. THE HANDLE, STEERING KNOB, AND ELECTRODES APPEARED TO BE INTACT. THE DEVICE DID NOT MEET THE CURVE SPECIFICATION. THE DEVICE DID NOT MEET THE PLANARITY SPECIFICATION. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE MOST LIKELY ROOT CAUSE IS MISHANDLING SUBSEQUENT TO DISTRIBUTION, INCLUDING SHIPPING/STORAGE CONDITIONS OR IMPROPER MANIPULATION OF THE CATHETER. THE INSTRUCTIONS FOR USE (IFU) STATE: DO NOT EXERT EXCESSIVE PRESSURE DURING PLACEMENT OF CATHETER IF UNKNOWN RESISTANCE IS ENCOUNTERED. DO NOT ATTEMPT TO USE THE REPROCESSED EP CATHETER PRIOR TO COMPLETELY READING AND UNDERSTANDING THE DIRECTIONS FOR USE. AVOID MANUAL PRE-BENDING OF DISTAL CURVE, AS THIS MAY DAMAGE STEERING MECHANISM OF STEERABLE CATHETERS. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED A CATHETER HAD AN INCORRECT CURVE. THE DEVICE WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS LESS THAN 30 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441913 NA CATHETER, RECORDING, ELECTRODE, REPROCESSED NLH STRYKER SUSTAINABILITY SOLUTIONS PHOENIX 81104 3970752 00885825009557

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown