BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 11018996 · Received December 16, 2020

    Report

    Report Number
    2522007-2020-00021
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 18, 2020
    Report Date
    June 18, 2021
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D2B ¿ PRODUCT CODE: DRE. G5 ¿ PMA/510(K): K14118. NO DEVICE WAS RETURNED ON THIS COMPLAINT, THEREFORE A PHYSICAL INVESTIGATION CAN NOT BE PERFORMED. THE COMPLAINT/EVENT THAT WAS ENTERED INTO TRACKWISE: "RIGHT ATRIAL PERFORATION RESULTING IN OPEN CHEST SURGERY." PER COMPLAINT ENTRY: "THE DEVICE WAS USED FOR NORMAL ICD/PACEMAKER LEAD EXTRACTION. THE TARGET LEAD WAS PLACED IN THE RIGHT ATRIUM VIA THE LEFT SUBCLAVIAN VEIN, INNOMINATE VEIN AND SVC. RIGHT AFTER REMOVING THE LEAD TIP FROM THE RIGHT ATRIUM WITH THE COMPLAINT DEVICE, BLOOD PRESSURE DROPPED UNDER 50MMHG. THE PHYSICIAN JUDGED THAT PERFORATION OCCURRED, SO OPEN CHEST SURGERY WAS PERFORMED. DURING THE SURGERY, THE PHYSICIAN CONFIRMED RIGHT ATRIAL PERFORATION FOR APPROXIMATELY 2CM WITH HIS/HER OWN EYES. THE RIGHT ATRIAL PERFORATION WAS REPAIRED. AFTER THE REPAIR, THE PATIENT'S CONDITION HAS BEEN STABLE." THE DEVICE HISTORY RECORD (DHR) FOR THIS LOT WAS REVIEWED AND THERE WERE NO SIGNS TO INDICATE THAT NONCONFORMING PRODUCT WAS MANUFACTURED AND SHIPPED TO THE FIELD. THIS COMPLAINT WILL BE MONITORED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN 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

    IT WAS REPORTED THAT THE COMPLAINT DEVICE, COOK LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-11.0-RL), WAS USED FOR AN ICD/PACEMAKER LEAD EXTRACTION. THE TARGET LEAD WAS PLACED IN THE RIGHT ATRIUM VIA THE LEFT SUBCLAVIAN VEIN, INNOMINATE VEIN AND SUPERIOR VENA CAVA. RIGHT AFTER REMOVING THE LEAD TIP FROM THE RIGHT ATRIUM WITH THE COMPLAINT DEVICE, THE PATIENT'S BLOOD PRESSURE DROPPED UNDER 50MMHG. THE PHYSICIAN JUDGED THAT A PERFORATION OCCURRED, THEREFORE, OPEN CHEST SURGERY WAS PERFORMED. DURING THE SURGERY, THE PHYSICIAN CONFIRMED A RIGHT ATRIAL PERFORATION FOR APPROXIMATELY 2CM WITH HIS/HER OWN EYES. THE RIGHT ATRIAL PERFORATION WAS REPAIRED. AFTER THE REPAIR, THE PATIENT'S CONDITION HAS BEEN STABLE.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE: DRE. PMA/510(K): K14118. (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPLAINT DEVICE, COOK LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET (LR-EVN-11.0-RL), WAS USED FOR AN IDC/PACEMAKER LEAD EXTRACTION. THE TARGET LEAD WAS PLACED IN THE RIGHT ATRIUM VIA THE LEFT SUBCLAVIAN VEIN, INNOMINATE VEIN AND SUPERIOR VENA CAVA. RIGHT AFTER REMOVING THE LEAD TIP FROM THE RIGHT ATRIUM WITH THE COMPLAINT DEVICE, THE PATIENT'S BLOOD PRESSURE DROPPED UNDER 50MMHG. THE PHYSICIAN JUDGED THAT A PERFORATION OCCURRED, THEREFORE, OPEN CHEST SURGERY WAS PERFORMED. DURING THE SURGERY, THE PHYSICIAN CONFIRMED A RIGHT ATRIAL PERFORATION FOR APPROXIMATELY 2CM WITH HIS/HER OWN EYES. THE RIGHT ATRIAL PERFORATION WAS REPAIRED. AFTER THE REPAIR, THE PATIENT'S CONDITION HAS BEEN STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485603 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC N171506

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention