BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    MDR report key: 19666916 · Received July 3, 2024

    Report

    Report Number
    2522007-2024-00022
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    April 29, 2024
    Report Date
    September 6, 2024
    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

    THIS WAS SENT FROM THE FDA IN THE 3500-SERIES FORM FILED UNDER MDR REPORT #: MW5155382. 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. G5 ¿ PMA/510(K): K141148. 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

    PER THE FOLLOWING D4 - UDI: 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 PER THIS COMPLAINT IS A MEDWATCH FROM THE FDA AND THE LOT/MODEL OF THE DEVICE WAS UNKNOWN. D4 - MODEL #: UNKNOWN. E3 - OCCUPATION: OTHER/UNKNOWN. G5 ¿ PMA/510(K): K141148. THIS WAS SENT FROM THE FDA IN THE 3500-SERIES FORM FILED UNDER MDR REPORT #: MW5155382. 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: "PERFORATION AND PERICARDIAL EFFUSION." 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. PER IFU ((B)(4)): "CATHETER/LEAD REMOVAL DEVICES SHOULD BE USED ONLY AT INSTITUTIONS WITH THORACIC SURGICAL CAPABILITIES.", "CATHETER/LEAD REMOVAL DEVICES SHOULD BE USED ONLY BY PHYSICIANS KNOWLEDGEABLE IN THE TECHNIQUES AND DEVICES FOR CATHETER/LEAD REMOVAL.", "PRIOR TO THE PROCEDURE, CONSIDER THE SIZE OF THE CATHETER/LEAD IN RELATION TO THE SIZE OF THE LEAD EXTRACTION¿ DEVICES TO DETERMINE POSSIBLE INCOMPATIBILITY.", "HAVE AVAILABLE AN EXTENSIVE COLLECTION OF SHEATHS, LOCKING STYLETS, STYLETS TO UNSCREW ACTIVE FIXATION LEADS, SNARES, AND ACCESSORY EQUIPMENT.", "IF EXCESSIVE SCAR TISSUE OR CALCIFICATION PREVENTS SAFE ADVANCEMENT OF SHEATH(S), CONSIDER AN ALTERNATE APPROACH.", "DUE TO RAPIDLY EVOLVING CATHETER/LEAD TECHNOLOGY, THIS DEVICE MAY NOT BE SUITABLE FOR THE REMOVAL OF ALL TYPES OF CATHETERS/LEADS. IF THERE ARE QUESTIONS OR CONCERNS REGARDING COMPATIBILITY OF THIS DEVICE WITH PARTICULAR CATHETERS/LEADS, CONTACT THE CATHETER/LEAD MANUFACTURER.", "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.", "WARNINGS: "WHEN USING SHEATHS, DO NOT INSERT SHEATHS OVER MORE THAN ONE LEAD AT A TIME. SEVERE VESSEL DAMAGE, INCLUDING VENOUS WALL LACERATION REQUIRING SURGICAL REPAIR, MAY OCCUR.", "CATHETER/LEAD REMOVAL DEVICES SHOULD BE USED ONLY AT INSTITUTIONS WITH THORACIC SURGICAL CAPABILITIES.", "CATHETER/LEAD REMOVAL DEVICES SHOULD BE USED ONLY BY PHYSICIANS KNOWLEDGEABLE IN THE TECHNIQUES AND DEVICES FOR CATHETER/LEAD REMOVAL.", "ESTABLISH BACK UP PACING AS NECESSARY.", "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.", "WHEN ADVANCING SHEATHS INCLUDING THE EVOLUTION OR EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, USE PROPER SHEATH TECHNIQUE AND MAINTAIN ADEQUATE TENSION ON THE CATHETER/LEAD (VIA A LOCKING STYLET OR DIRECTLY) TO AVOID DAMAGE TO VESSEL WALLS.", "IF EXCESSIVE 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.", "IF THE CATHETER/LEAD BREAKS, EVALUATE FRAGMENT; RETRIEVE AS INDICATED.", "IF HYPOTENSION DEVELOPS, RAPIDLY EVALUATE; TREAT AS APPROPRIATE."", "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

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD FRACTURE, IMPLANTED FROM A RIGHT SIDED ACCESS. A (B)(6) LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. MULTIPLE (B)(6) DEVICES (14F GLIDELIGHT LASER SHEATH, 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH) WERE USED TO ATTEMPT REMOVAL OF THE LEAD, BUT ADVANCEMENT COULD BE MADEONLY TO THE AREA OF THE CLAVICLE. AT THAT TIME, THE DECISION WAS MADE TO UTILIZE A COOK MEDICAL EVOLUTION DILATOR SHEATH TO ATTEMPT FURTHER ADVANCEMENT, AND PROGRESS WAS MADE TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) REGION. HOWEVER, AT THAT TIME, EVEN THOUGH THE PATIENT'S BLOOD PRESSURE REMAINED STABLE, AN EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN INNOMINATE/SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. NO (B)(6) DEVICES HAD ADVANCED TO THE AREA OF INJURY. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE EVOLUTION 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

    AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) LEAD DUE TO LEAD FRACTURE, IMPLANTED FROM A RIGHT SIDED ACCESS. A (B)(6) LEAD LOCKING DEVICE (LLD) WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. MULTIPLE (B)(6) DEVICES (14F GLIDELIGHT LASER SHEATH, 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH) WERE USED TO ATTEMPT REMOVAL OF THE LEAD, BUT ADVANCEMENT COULD BE MADE ONLY TO THE AREA OF THE CLAVICLE. AT THAT TIME, THE DECISION WAS MADE TO UTILIZE A COOK MEDICAL EVOLUTION DILATOR SHEATH TO ATTEMPT FURTHER ADVANCEMENT, AND PROGRESS WAS MADE TO THE INNOMINATE/SUPERIOR VENA CAVA (SVC) REGION. HOWEVER AT THAT TIME, EVEN THOUGH THE PATIENT'S BLOOD PRESSURE REMAINED STABLE, AN EFFUSION WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY. AN INNOMINATE/SVC PERFORATION WAS DISCOVERED AND REPAIRED, AND THE PATIENT SURVIVED THE PROCEDURE. NO (B)(6) DEVICES HAD ADVANCED TO THE AREA OF INJURY. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE EVOLUTION 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
    821922 LEAD EXTRACTION EVOLUTION 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 40 YR Male Other 13F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH.| 14F GLIDELIGHT LASER SHEATH.| LEAD LOCKING STYLET G26550-LR-OFA01.