BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 3871793 · Received June 13, 2014

    Report

    Report Number
    9616099-2014-00380
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DYB
    PMA / PMN Number
    K984500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING A BRITE TIP SHEATH AND THEN NOTED THAT THE DISTAL TIP OF THE DILATOR WAS FRAYED. THE PHYSICIAN REPLACED THE BRITE TIP FOR A NON-CORDIS SHEATH AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE ACCESS SITE VESSEL CHARACTERISTICS ARE UNKNOWN. THE TARGET LESION WAS NOT TORTUOUS BUT MILDLY CALCIFIED WITH AN UNKNOWN RATE OF STENOSIS. NO ANOMALIES WERE NOTED DURING PREPPING OR PRIOR TO INSERTION OF THE DEVICE INTO THE PATIENT. NO EXCESSIVE TORQUEING WAS USED DURING THE INSERTION OF THE DEVICE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS OR PICTURES OF THE EVENT, THE REPORTED COMPLAINT ¿BRITE TIP/DISTAL TIP FRAYED/SPLIT/TORN¿ AND ¿CATHETER SHEATH INTRODUCER-INSERTION DIFFICULTY¿ COULD NOT BE CONFIRMED AND AN EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, ACCESS SITE VESSEL CHARACTERISTICS ARE UNKNOWN BUT MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW SUGGEST THAT THE REPORTED COMPLAINT COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 16087680 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO AN UNKNOWN TARGET LESION. THE PHYSICIAN TRIED TO INSERT A BRITE TIP SHEATH BUT THERE WAS DIFFICULTY INSERTING IT. FURTHERMORE, THE DISTAL TIP OF THE DILATOR WAS NOTED TO BE FRAYED DURING THE INSERTION. THEREFORE, THE PHYSICIAN STOPPED USING THE SHEATH INTRODUCER AND USED A NON-CORDIS SHEATH. THE PROCEDURE FINISHED SUCCESSFULLY AND THERE WAS NO PATIENT INJURY REPORTED. NO ANOMALIES WERE NOTED DURING THE PREPPING OR PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. NO EXCESSIVE TORQUE WAS USED DURING THE INSERTION. THE ASSESS SITE VESSEL CHARACTERISTICS ARE UNKNOWN. THE TARGET LESION WAS MILDLY CALCIFIED AND NOT TORTUOUS. THE RATE OF STENOSIS IS UNKNOWN. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. NO PICTURES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350946 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 16087680

    Patients

    Seq Age Sex Outcome Treatment
    1