BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2152670 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04811
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND THE DEVICE FULLY CLIP DEPLOYED. THE SHEATH HAD BEEN COMPLETELY SLIT, THE PLUNGER PARTIALLY RETRACTED, THUMB ADVANCER ADVANCED FULLY FORWARD, AND THE TUBESET IN NORMAL CLIP DEPLOYMENT ALIGNMENT. INTERNAL ANALYSIS SHOWED NO DEVICE ANOMALIES WITH THE DEVICE COMPONENTS OR THE COMPONENTS POSITIONED IN THE DEVICE (RELEASE ROD WITHIN HANDLE CHANNEL, PROPER ALIGNMENT OF THE TUBESET). THE DEVICE WAS REASSEMBLED, MINUS THE CLIP, AND DEPLOYED NORMALLY. REPORTEDLY, THE TWO POTENTIAL FAILURES THAT WERE OBSERVED DURING THE USE OF THE DEVICE WERE, THE PLUNGER POPPED OUT OF POSITION DURING THUMB ADVANCEMENT AND THAT THERE WAS DIFFICULTY ADVANCING THE THUMB ADVANCER. THE PLUNGER CAN MOVE OUT OF POSITION AFTER BEING DEPLOYED BY USING THE SAFETY SWITCH OR DEPRESSING THE TRIGGER BUTTON AS PART OF DEPLOYMENT. INTERNAL COMPONENT INTERACTION COULD POTENTIALLY HAVE TRIGGERED THE PLUNGER RETRACTION, BUT DEVICE ANALYSIS DID NOT DETECT ANY COMPONENT DEFECTS. THE MOST LIKELY CAUSE FOR THE OBSERVED RETRACTION OF THE PLUNGER DURING THUMB ADVANCEMENT INDICATES THE SAFETY RELEASE WAS DEPRESSED. THE REPORTED EVENT INDICATED THE THUMB ADVANCEMENT WAS DIFFICULT, SIGNIFYING HAND ADJUSTMENTS MAY HAVE BEEN NECESSARY TO COMPLETE THE ADVANCEMENT. THIS COULD POTENTIALLY ACTIVATE THE SAFETY RELEASE AND THEREBY RETRACT THE PLUNGER. THE USE OF THE SAFETY RELEASE DURING THUMB ADVANCEMENT IS ALSO RE-ENFORCED BY THE OBSERVATION OF THE CLIP BEING DEPLOYED INTO SUBCUTANEOUS TISSUE. ONCE THE PLUNGER IS DEPLOYED, IT LOCATES THE VESSEL BY DEPLOYING THE VESSEL LOCATOR WINGS. WHEN THE PLUNGER RETRACTS, THE LOCATION OF THE VESSEL IS LOST, THUS, WHEN THE THUMB ADVANCEMENT WAS COMPLETED AND THE CLIP FIRED, IT WAS FIRED INTO THE TISSUE. USING THE SAFETY RELEASE DOES NOT PREVENT THE COMPLETION OF THUMB ADVANCEMENT. THE DIFFICULT TO ADVANCE THE THUMB ADVANCER WAS MOST LIKELY DUE TO THE TISSUE RESISTANCE, BECAUSE THE DEVICE WAS REPORTEDLY USED IN AN OBESE PATIENT. THE STARCLOSE SE INSTRUCTIONS FOR USE STATES: DO NOT ADVANCE OR WITHDRAW THE STARCLOSE SE VASCULAR CLOSURE DEVICE AGAINST RESISTANCE UNTIL THE CAUSE OF THAT RESISTANCE HAS BEEN DETERMINED. EXCESSIVE FORCE USED TO ADVANCE OR TORQUE THE STARCLOSE SE DEVICE SHOULD BE AVOIDED, AS THIS MAY LEAD TO SIGNIFICANT VESSEL DAMAGE AND/OR BREAKAGE OF THE DEVICE, WHICH MAY NECESSITATE INTERVENTIONAL AND/OR SURGICAL REMOVAL OF THE DEVICE AND VESSEL REPAIR. THE CAUSE OF THIS EVENT WAS MOST LIKELY DUE TO THE SIZE OF THE PATIENT AND THE USE OF SAFETY RELEASE BUTTON DURING THUMB ADVANCEMENT. THE RISK OF THIS FORESEEABLE EVENT WAS PREDICTED TO BE LOW, AND IS COMMENSURATED WITH THE POTENTIAL HAZARD AND PATIENT EFFECT. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED NO OTHER SIMILAR INCIDENTS FROM THIS LOT. BASED ON THIS INVESTIGATION, THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE. REPORTEDLY, WHILE ADVANCING THE THUMB ADVANCER, THE PLUNGER "POPPED" OUT. DIFFICULTY WAS ENCOUNTERED WHILE COMPLETING THE SHEATH SPLIT; HOWEVER, THE CLIP WAS FIRED BUT HAD DEPLOYED IN THE SUBCUTANEOUS TISSUE. HEMOSTASIS WAS ACHIEVED BY USING A NON-ABBOTT DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. IT WAS REPORTED THAT THE PHYSICIAN WAS PROFICIENT IN THE USE OF THE DEVICE. NO CLINICALLY SIGNIFICANT DELAY IN THE INTERVENTIONAL PROCEDURE WAS REPORTED. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT 050076H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 6F