BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SI BRITE TIP

    MDR report key: 3132614 · Received May 29, 2013

    Report

    Report Number
    9616099-2013-00324
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 7, 2013
    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

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT WAS PERFORMED AND THE FOLLOWING WAS FOUND: REVIEW OF LOT 15787754 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE 23 CM. 6 FR. SI BRITE TIP STR SHEATH INTO THE PATIENT. THE DISTAL PORTION (MARKER) OF THE SHEATH WAS NOTED TO BE FRAYED. ANOTHER (NON-CORDIS) LONG SHEATH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE ACCESS SITE WAS THE FEMORAL ARTERY. NO TARGET LESION/LESION CHARACTERISTIC INFORMATION WAS AVAILABLE. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. WITHOUT HAVING THE PRODUCT RETURNED FOR ANALYSIS, THE COMPLAINT COULD NOT BE CONFIRMED. THE INSERTION DIFFICULTY MAY HAVE CONTRIBUTED TO THE FRAYED CONDITION. INSERTION DIFFICULTY IS OFTEN RELATED TO ACCESS SITE VESSEL CHARACTERISTICS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ¿IF INCREASED RESISTANCE IS FELT UPON INSERTION OF THE CATHETER SHEATH INTRODUCER (CSI), INVESTIGATE THE CAUSE BEFORE CONTINUING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED AND CORRECTED, DISCONTINUE THE PROCEDURE AND WITHDRAW THE CSI¿. THERE IS NO EVIDENCE THAT THE COMPLAINT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE 23 CM 6 FR SI BRITE TIP STR SHEATH INTO THE PATIENT. THE DISTAL PORTION (MARKER) OF THE SHEATH WAS NOTED TO BE FRAYED. ANOTHER (NON-CORDIS) LONG SHEATH WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE ACCESS SITE WAS THE FEMORAL ARTERY. NO TARGET LESION/LESION CHARACTERISTIC INFORMATION WAS AVAILABLE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236185 SI BRITE TIP ENDOVASCULAR VASCULAR ACCESS (DYB) DYB CORDIS DE MEXICO NA 15787754

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO 6F SHORT SHEATH