BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 19766641 · Received July 17, 2024

    Report

    Report Number
    2522007-2024-00024
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    January 9, 2024
    Report Date
    September 9, 2024
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. D2B ¿ PRODUCT CODE: DRE. G5 ¿ PMA/510(K): 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 UNKNOWN. D4 - MODEL: UNKNOWN. E3 - OCCUPATION: ASSISTANT DIRECTOR. G5 ¿ PMA/510(K): K141148. 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: "CUT THE NONTARGETED RA LEAD, REQUIRING INTERVENTION TO REPLACE." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN 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

    A COOK MEDICAL EVOLUTION SHORTIE DILATOR SHEATH WAS USED TO REMOVE A TARGETED RIGHT VENTRICULAR (RV) LEAD WHEN ADJACENT LEAD DAMAGE OCCURRED ON A RIGHT ATRIAL (RA) LEAD, REQUIRING IT TO BE REPLACED (THE RA LEAD WAS NOT ORIGINALLY TARGETED FOR REMOVAL). ALTHOUGH A (B)(6) GLIDELIGHT LASER SHEATH WAS IN USE DURING THE PROCEDURE AS WELL, THE PHYSICIAN STATED IT WAS THE COOK SHORTIE WHICH CUT THE NONTARGETED RA LEAD, REQUIRING INTERVENTION TO REPLACE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE EVOLUTION SHORTIE DILATOR SHEATH. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Description of Event or Problem · 0

    A COOK MEDICAL EVOLUTION SHORTIE DILATOR SHEATH WAS USED TO REMOVE A TARGETED RIGHT VENTRICULAR (RV) LEAD WHEN ADJACENT LEAD DAMAGE OCCURRED ON A RIGHT ATRIAL (RA) LEAD, REQUIRING IT TO BE REPLACED (THE RA LEAD WAS NOT ORIGINALLY TARGETED FOR REMOVAL). ALTHOUGH A (B)(6) GLIDELIGHT LASER SHEATH WAS IN USE DURING THE PROCEDURE AS WELL, THE PHYSICIAN STATED IT WAS THE COOK SHORTIE WHICH CUT THE NONTARGETED RA LEAD, REQUIRING INTERVENTION TO REPLACE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE EVOLUTION SHORTIE DILATOR SHEATH. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364497 LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION DRE COOK VANDERGRIFT INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other GLIDELIGHT LASER SHEATH.