BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 13995645 · Received April 4, 2022

    Report

    Report Number
    2522007-2022-00011
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    March 17, 2022
    Report Date
    July 11, 2022
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: DRE. PMA/510(K): K141148. 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.

    Additional Manufacturer Narrative · 0

    D2B: PRODUCT CODE: DRE. G5: PMA/510(K): K141148. DEVICE WAS NOT RETURNED, THEREFORE A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED INTO TRACKWISE: "TRICUSPID REGURGITATION." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED BECAUSE THE LOT WAS UNKNOWN FOR THE DEVICE. THIS COMPLAINT CODE WILL BE TRACKED, TRENDED AND MONITOR PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. THERE WILL BE A RISK ASSESSMENT WITHIN TRACKWISE IN THE COMPLAINT SUMMARY TAB. 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 A PACEMAKER WAS IMPLANTED IN THE LEFT CHEST, AND THROUGH THE LEFT SUBCLAVIAN VEIN, A RIGHT ATRIAL LEAD (PACE MAKER LEAD) AND RIGHT VENTRICULAR LEAD (ICD LEAD) HAD BEEN PLACED IN THE RIGHT ATRIUM AND THE RIGHT VENTRICLE RESPECTIVELY. LR-OFA01 DEVICE WAS USED FOR THE PACEMAKER LEAD IN THE RIGHT ATRIUM AND LR-LED01/PHILIPS WAS USED FOR THE ICD LEAD IN THE RIGHT VENTRICLE. LLD-EG /PHILIPS (LOCKING STYLET) WAS USED TO HOLD THE CABLE OF ICD LEAD, WHERE BOTH LOCKING STYLETS WERE USED WITH SUPERIOR APPROACH FROM SUPERIOR VENA CAVA (SVC). IN ORDER TO KEEP THE LEADS AWAY FROM THE SVC AND TO KEEP THE LEADS COAXIAL WITH THE DILATOR SHEATH, LR-NES002 USED DURING PROCEDURE. WHILE LR-NES002 WAS BEING USED WITH THE RIGHT INGUINAL APPROACH, THE GLIDE LIGHT 12FR/PHILIPS WAS USED WITH THE LEFT SUBCLAVIAN APPROACH, BUT AS SOON AS IT ENTERED THE SVC IT GOT STUCK WHEN IT WAS ADVANCED TILL AROUND THE INNOMINATE VEIN, THE DOCTOR DECIDED THE LASER WAS NOT SUITABLE FOR THIS CASE AND USED LR-EVN-SH-9.0-RL INSTEAD. THE DOCTOR TRIED TO DETACH THE LEAD WITH LR-EVN-SH-9.0-RL, BUT HE WAS UNABLE TO DO SO AROUND WHEN IT ENTERED THE SVC, SO HE SWITCHED TO THE LR-EVN-11.0-RL AND BOTH LEADS WERE REMOVED. USING LARGER FRENCH DEVICE WAS NECESSARY DUE TO STRONG ADHESION BASED ON THE DEGREE OF THE ADVANCEMENT OF THE DEVICE, HENCE THE LR-EVN-11.0-RL WAS USED. AFTER BOTH LEADS WERE REMOVED AND A NEW LEAD WAS IMPLANTED, ECHOCARDIOGRAPHY REVEALED THAT BLOOD FLOW WAS REGURGITATED. NO ADDITIONAL PROCEDURES WERE PERFORMED, PATIENT REGAINED CONSCIOUSNESS AND DID NOT APPEAR TO HAVE CHANGED IN ANY PARTICULAR WAY AND AS OF (B)(6), PATIENT REMAINS IN THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PACEMAKER WAS IMPLANTED IN THE LEFT CHEST, AND THROUGH THE LEFT SUBCLAVIAN VEIN, A RIGHT ATRIAL LEAD (PACE MAKER LEAD) AND RIGHT VENTRICULAR LEAD (ICD LEAD) HAD BEEN PLACED IN THE RIGHT ATRIUM AND THE RIGHT VENTRICLE RESPECTIVELY. LR-OFA01 DEVICE WAS USED FOR THE PACEMAKER LEAD IN THE RIGHT ATRIUM AND LR-LED01/PHILIPS WAS USED FOR THE ICD LEAD IN THE RIGHT VENTRICLE. LLD-EG /PHILIPS (LOCKING STYLET) WAS USED TO HOLD THE CABLE OF ICD LEAD, WHERE BOTH LOCKING STYLETS WERE USED WITH SUPERIOR APPROACH FROM SUPERIOR VENA CAVA (SVC). IN ORDER TO KEEP THE LEADS AWAY FROM THE SVC AND TO KEEP THE LEADS COAXIAL WITH THE DILATOR SHEATH, LR-NES002 USED DURING PROCEDURE. WHILE LR-NES002 WAS BEING USED WITH THE RIGHT INGUINAL APPROACH, THE GLIDE LIGHT 12FR/PHILIPS WAS USED WITH THE LEFT SUBCLAVIAN APPROACH, BUT AS SOON AS IT ENTERED THE SVC IT GOT STUCK WHEN IT WAS ADVANCED TILL AROUND THE INNOMINATE VEIN, THE DOCTOR DECIDED THE LASER WAS NOT SUITABLE FOR THIS CASE AND USED LR-EVN-SH-9.0-RL INSTEAD. THE DOCTOR TRIED TO DETACH THE LEAD WITH LR-EVN-SH-9.0-RL, BUT HE WAS UNABLE TO DO SO AROUND WHEN IT ENTERED THE SVC, SO HE SWITCHED TO THE LR-EVN-11.0-RL AND BOTH LEADS WERE REMOVED. USING LARGER FRENCH DEVICE WAS NECESSARY DUE TO STRONG ADHESION BASED ON THE DEGREE OF THE ADVANCEMENT OF THE DEVICE, HENCE THE LR-EVN-11.0-RL WAS USED. AFTER BOTH LEADS WERE REMOVED AND A NEW LEAD WAS IMPLANTED, ECHOCARDIOGRAPHY REVEALED THAT BLOOD FLOW WAS REGURGITATED. NO ADDITIONAL PROCEDURES WERE PERFORMED, PATIENT REGAINED CONSCIOUSNESS AND DID NOT APPEAR TO HAVE CHANGED IN ANY PARTICULAR WAY AND AS OF MARCH 18, PATIENT REMAINS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619424 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization LR-NES002| LR-OFA01 LR-LED01 LR-EVN-SH-9.0-RL LR-NES002