BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 10929066 · Received December 1, 2020

    Report

    Report Number
    2522007-2020-00020
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 6, 2020
    Report Date
    June 18, 2021
    Manufacturer
    COOK VANDERGRIFT INC
    Product Code
    DRE
    UDI-DI
    10827002237473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. D2B ¿ PRODUCT CODE: DRE. D11 ¿ CONCOMITANT DEVICES: PHILIPS GLIDELIGHT 14FR SHEATH, PHILIPS GLIDELIGHT 16FR. G5 ¿ PMA/510(K): K14118. NO DEVICE WAS RETURNED TO CVI, THEREFORE A PHYSICAL INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND THERE WERE NO SIGNS TO INDICATE THIS DEVICE WAS SHIPPED NONCONFORMING OR THAT IT DID NOT MEET MANUFACTURING SPECIFICATIONS.THIS COMPLAINT WILL BE MONITORED AND TRENDED THROUGH THE CVI COMPLAINT HANDLING AND POST MARKED SURVEILLANCE PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB OF TRACKWISE. PER IFU (D00078684 REV 002): "CATHETER/LEAD REMOVAL DEVICES SHOULD BE USED ONLY BY PHYSICIANS KNOWLEDGEABLE IN THE TECHNIQUES AND DEVICES FOR CATHETER/LEAD REMOVAL.", "HAVE AVAILABLE AN EXTENSIVE COLLECTION OF SHEATHS, LEAD CONTROL DEVICES (LOCKING STYLET AND LEAD EXTENDER), STYLETS TO UNSCREW ACTIVE FIXATION LEADS, SNARES, AND ACCESSORY EQUIPMENT.", "IF EXTENSIVE SCAR TISSUE OR CALCIFICATION PREVENTS SAFE ADVANCEMENT OF SHEATHS, CONSIDER AN ALTERNATE APPROACH.", "EXCESSIVE FORCE WITH SHEATHS, INCLUDING THE EVOLUTION OR EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET USED INTRAVASCULARLY MAY RESULT IN DAMAGE TO THE VASCULAR SYSTEM REQUIRING SURGICAL REPAIR." & "POTENTIAL ADVERSE EVENTS RELATED TO THE PROCEDURE OF INTRAVASCULAR EXTRACTION OF CATHETERS/LEADS INCLUDE (LISTED IN ORDER OF INCREASING POTENTIAL EFFECT): DISLODGING OR DAMAGING NONTARGETED CATHETER/LEAD, CHEST WALL HEMATOMA, THROMBOSIS, ARRHYTHMIAS, ACUTE BACTEREMIA, ACUTE HYPOTENSION, PNEUMOTHORAX, STROKE, MIGRATING FRAGMENT FROM CATHETER/OBJECT, PULMONARY EMBOLISM, LACERATION OR TEARING OF VASCULAR STRUCTURES OR THE MYOCARDIUM, HEMOPERICARDIUM/PERICARDIAL EFFUSION, CARDIAC TAMPONADE, HEMOTHORAX, CARDIAC ARREST, DEATH". 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 TRANSVENOUS LEAD EXTRACTION PROCEDURE WAS PERFORMED, APPROACHING FROM THE SUBCLAVIAN VEIN. THE TARGET LEAD WAS AN ICD LEAD IMPLANTED FOR 12 YEARS. A PHILIPS GLIDELIGHT 14FR SHEATH WAS ADVANCED TO PEEL OFF THE ADHESION, BUT BECAUSE IT STOPPED ADVANCING AT THE SUBCLAVIAN VEIN, THE SHEATH WAS CHANGED WITH PHILIPS GLIDELIGHT 16FR. HOWEVER, THE 16FR GLIDELIGHT SHEATH STOPPED ADVANCING AT THE ELECTRODE COIL OF THE LEAD (PRIOR TO PASSING THROUGH THE ELECTRODE COIL), SO IT WAS EXCHANGED WITH THE COOK EVOLUTION (RL) CONTROLLED-ROTATING DILATOR SHEATH SET (LR-EVN-13.0-RL). THOUGH THE USER FELT ADVANCEMENT DIFFICULTY AT THE ELECTRODE COIL OF THE LEAD AS HE DID WITH THE PHILIPS LASER SHEATH, HE WAS ABLE TO ADVANCE THE EVOLUTION LITTLE BY LITTLE AND REACHED THE TIP OF THE LEAD, THEN THE ICD LEAD COULD BE EXTRACTED WITH COOK¿S LR-OFA01. THE PATIENT¿S BLOOD PRESSURE DECREASED AFTER THAT, BUT BECAUSE IT RECOVERED, THE USER MOVED TO EXTRACTION OF ATRIAL LEAD. THE ATRIAL LEAD COULD BE EXTRACTED WITH PHILIPS¿ LASER SHEATH 14FR AND LOCKING DEVICE (LLD-EZ) EASILY. THOUGH THE BLOOD PRESSURE WAS NOT STABLE, A SHEATH WAS INSERTED IN ORDER TO PLACE A NEW LEAD. THE PHYSICIAN CHECKED TO BE SURE A TAMPONADE WAS NOT OCCURRING WITH ECHO AT THE SAME TIME, THEN FOUND A BLOOD FLOW LEAKING TO OUTSIDE THE VESSEL AROUND THE SUPERIOR VENA CAVA (SVC). AN ANGIOGRAPHY PERFORMED FROM THE SUBCLAVIAN VEIN CONFIRMED THE SAME BLOOD FLOW, SO ANOTHER (UNKNOWN) MANUFACTURER¿S EVT BALLOON 10MM X 6CM WAS USED TO DEAL WITH THE BLOOD LEAKAGE. HOWEVER, IT APPEARED THAT THE TREATMENT WITH THE BALLOON MADE THE DAMAGE WORSE. BLOOD TRANSFUSION WAS MADE (THE AMOUNT IS UNKNOWN), THEN THE PATIENT WAS MOVED TO THE OPERATION ROOM. OPEN CHEST SURGERY WAS PERFORMED TO REPAIR THE DAMAGED SVC. THE OPERATION WAS FINISHED SUCCESSFULLY. THE PATIENT¿S CONDITION IS STABLE; HOWEVER, PARAPLEGIA WAS CONFIRMED PROBABLY DUE TO THE OPERATION TO TREAT THE DAMAGED SVC AND MAY REMAIN WITH THE PATIENT AS AN AFTER-EFFECT. MEDICAL AFFAIRS REVIEWED THIS COMPLAINT AND DETERMINED THAT THE PARAPLEGIA MAY HAVE BEEN CAUSED BY THE LOW BLOOD CONDITION. THERE IS NO DIRECT LINK TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: CUSTOMER PERSON: POSTAL CODE (B)(6). PRODUCT CODE: DRE. CONCOMITANT DEVICES: PHILIPS GLIDELIGHT 14FR SHEATH, PHILIPS GLIDELIGHT 16FR. 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 A TRANSVENOUS LEAD EXTRACTION PROCEDURE WAS PERFORMED, APPROACHING FROM THE SUBCLAVIAN VEIN. THE TARGET LEAD WAS AN ICD LEAD IMPLANTED FOR 12 YEARS. A PHILIPS GLIDELIGHT 14FR SHEATH WAS ADVANCED TO PEEL OFF THE ADHESION, BUT BECAUSE IT STOPPED ADVANCING AT THE SUBCLAVIAN VEIN, THE SHEATH WAS CHANGED WITH PHILIPS GLIDELIGHT 16FR. HOWEVER, THE 16FR GLIDELIGHT SHEATH STOPPED ADVANCING AT THE ELECTRODE COIL OF THE LEAD (PRIOR TO PASSING THROUGH THE ELECTRODE COIL), SO IT WAS EXCHANGED WITH THE COOK EVOLUTION (RL) CONTROLLED-ROTATING DILATOR SHEATH SET (LR-EVN-13.0-RL). THOUGH THE USER FELT ADVANCEMENT DIFFICULTY AT THE ELECTRODE COIL OF THE LEAD AS HE DID WITH THE PHILIPS LASER SHEATH, HE WAS ABLE TO ADVANCE THE EVOLUTION LITTLE BY LITTLE AND REACHED THE TIP OF THE LEAD, THEN THE ICD LEAD COULD BE EXTRACTED WITH COOK¿S LR-OFA01. THE PATIENT¿S BLOOD PRESSURE DECREASED AFTER THAT, BUT BECAUSE IT RECOVERED, THE USER MOVED TO EXTRACTION OF ATRIAL LEAD. THE ATRIAL LEAD COULD BE EXTRACTED WITH PHILIPS¿ LASER SHEATH 14FR AND LOCKING DEVICE (LLD-EZ) EASILY. THOUGH THE BLOOD PRESSURE WAS NOT STABLE, A SHEATH WAS INSERTED IN ORDER TO PLACE A NEW LEAD. THE PHYSICIAN CHECKED TO BE SURE A TAMPONADE WAS NOT OCCURRING WITH ECHO AT THE SAME TIME, THEN FOUND A BLOOD FLOW LEAKING TO OUTSIDE THE VESSEL AROUND THE SUPERIOR VENA CAVA (SVC). AN ANGIOGRAPHY PERFORMED FROM THE SUBCLAVIAN VEIN CONFIRMED THE SAME BLOOD FLOW, SO ANOTHER (UNKNOWN) MANUFACTURER¿S EVT BALLOON 10MM X 6CM WAS USED TO DEAL WITH THE BLOOD LEAKAGE. HOWEVER, IT APPEARED THAT THE TREATMENT WITH THE BALLOON MADE THE DAMAGE WORSE. BLOOD TRANSFUSION WAS MADE (THE AMOUNT IS UNKNOWN), THEN THE PATIENT WAS MOVED TO THE OPERATION ROOM. OPEN CHEST SURGERY WAS PERFORMED TO REPAIR THE DAMAGED SVC. THE OPERATION WAS FINISHED SUCCESSFULLY. THE PATIENT¿S CONDITION IS STABLE; HOWEVER, PARAPLEGIA WAS CONFIRMED PROBABLY DUE TO THE OPERATION TO TREAT THE DAMAGED SVC AND MAY REMAIN WITH THE PATIENT AS AN AFTER-EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1393769 LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VANDERGRIFT INC G23747 N170079 10827002237473

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention