BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2152452 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04802
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION FOUND THAT THE DEVICE WAS RETURNED FULLY CLIP-DEPLOYED AND THE CONDITION SUBSTANTIATED THE REPORTED PRODUCT EXPERIENCE. INSPECTION SUGGESTED THAT THE LOCATOR WINGS WERE INITIALLY BENT DURING THE THUMB ADVANCER DEPLOYMENT DUE TO TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS, PREVENTING THE WINGS FROM FULLY COLLAPSING INTO THE DELIVERY TUBESET WHEN THE CLIP WAS FIRED. THE FAILURE OF THE WINGS TO COMPLETELY COLLAPSE INTO THE DELIVERY TUBESET DIRECTLY RESULTED IN DIFFICULT DEVICE REMOVAL. CONSISTENT WITH THE REPORTED INFORMATION, THE ACCESS PORTS AND SAFETY RELEASE WERE FOUND TO HAVE BEEN UTILIZED TO FACILITATE THE DEVICE REMOVAL AS INSTRUCTED IN THE INSTRUCTIONS FOR USE (IFU). HOWEVER, THE DEVICE COULD NOT BE RELEASED FROM THE ARTERY DUE TO BENT WINGS THAT PREVENTED THEM FROM COLLAPSING INTO THE TUBESET. ASSERTIVE PULL WAS APPLIED WHICH RESULTED IN ALL OF THE WINGS DETACHING FROM THE DISTAL RETAINING RING, BUT REMAINED SECURELY ATTACHED WITHIN THE LOCATOR. THE SAFETY RELEASE BUTTON WAS DISLOCATED, BUT IS NOT CONSIDERED A FAILURE MODE OF THE DEVICE BECAUSE OF THE ATTEMPTED USE TO RETRACT THE LOCATOR WINGS TO REMOVE THE DEVICE. POSSIBLE CONTRIBUTING FACTORS FOR DAMAGED VESSEL LOCATOR WINGS INCLUDED, BUT NOT LIMITED TO MANUFACTURING; HOWEVER, EVERY VESSEL LOCATOR WINGS ASSEMBLY WAS PROPERLY ASSEMBLED AND INSPECTED DURING MANUFACTURING. ANATOMICAL CONDITIONS; HOWEVER, THERE WERE NO CHALLENGING ANATOMICAL CONDITIONS REPORTED. DEPLOYMENT TECHNIQUE; HOWEVER, THERE WAS NO INFORMATION REPORTED OR DEFINITIVE EVIDENCE IN THE EVALUATION OF THE RETURNED DEVICE THAT SUGGEST INCORRECT TECHNIQUE. BASED ON THE INVESTIGATION FINDINGS, THE PROBABLE CAUSE FOR THE DAMAGED LOCATOR WINGS (BENT AND BROKEN) THAT DIRECTLY RESULTED IN THE REPORTED DIFFICULT DEVICE REMOVAL IS TISSUE COMPACTION THAT EXERTED A DISTAL FORCE ON THE WINGS WHILE IN THE TISSUE TRACT. TISSUE TRAPPED BETWEEN THE DISTAL END OF THE TUBESET AND THE LOCATOR WINGS CAN BEND THE WINGS AND EVENTUALLY BREAK THEM DURING FORCEFUL REMOVAL. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. PATIENT AGE WAS REPORTED TO BE IN THEIR MID (B)(6). DATE OF OCCURRENCE IS ESTIMATED TO BE (B)(6) 2011 PATIENT WEIGHT WAS REPORTED TO BE (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN ACHIEVED ARTERIOTOMY CLOSURE USING A STARCLOSE SE DEVICE IN THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, AFTER DEPLOYING THE CLIP, THERE WAS DIFFICULTY IN REMOVING THE DEVICE FROM THE ANATOMY. PER THE INSTRUCTIONS FOR USE, THE ACCESS PORTS AND SAFETY RELEASE BUTTON WERE USED BUT THE DEVICE COULD NOT BE REMOVED. THE DEVICE WAS PULLED OUT OF THE ANATOMY; HOWEVER HEMOSTASIS WAS ACHIEVED BY THE DEPLOYED CLIP. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN WAS REPORTED TO BE PROFICIENT IN THE USE OF THE STARCLOSE SE DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE INTERVENTIONAL PROCEDURE. 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 030296H

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SHEATH, 6FR