BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH TEMPO 5

    MDR report key: 2111216 · Received June 2, 2011

    Report

    Report Number
    9616099-2011-00375
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 8, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K973401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT WHEN THE PACKAGES WERE OPENED TWO TEMPO GUIDE CATHETERS WERE CRACKED PRIOR TO USE. THERE ARE NO PATIENT, VESSEL OR TARGET LESION DETAILS AVAILABLE TO DATE. TWO TEMPO GUIDING CATHETERS WERE BROKEN/CRACKED. WHEN THE PHYSICIAN OPENED THE PACKAGE, HE FOUND ONE CATHETER TIP WAS NEARLY BROKEN AND THE OTHER CATHETER TIP WAS CRACKED. THE PRODUCT S WILL BE RETURNED FOR INVESTIGATION. THE PRODUCTS HAD NOT BEEN COMPLETELY REMOVED FROM THE PACKAGE. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGE. THE DEVICE WAS NOT RE-PROCESSED. THE DEVICES WERE NOT CLINICALLY USED AND THERE IS NO REPORT OF INJURY FOR THE PATIENT. TWO NON STERILE UNITS OF TEMPO FR 5 WERE RECEIVED COILED INSIDE A PLASTIC BAG. BOTH SAMPLES PRESENT SEVERAL CRACKS AT LENGTH BODY. THE RECEIVED HUBS PRESENTED A DIFFERENT COLOR THAN A LAB SAMPLE HUB. NO ADDITIONAL ANOMALIES WERE OBSERVED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. A SEM ANALYSIS WAS DEVELOPED AND SEVERAL CRACKS AND MICRO CRACKS WERE OBSERVED NEAR THE SEPARATION SECTIONS, CRACKING IS A COMMON CHARACTERISTIC OF BRITTLENESS OR DEGRADATION OF THE MATERIAL. THE RECEIVED HUB PRESENTED A DIFFERENT COLOR THAN A LAB SAMPLE HUB; THIS SUGGESTS POSSIBLE DEGRADATION OF THE HUB MATERIAL. SEPARATION SURFACES WERE EXPOSED AND NO VISUAL EVIDENCE OF ANY CHEMICAL ATTACK WAS NOTED. CUTTING WAS DISCARDED AS A FAILURE CAUSE SINCE NO CHARACTERISTICS TYPICAL OF THIS FAILURE MODE WERE OBSERVED. THE EXACT CAUSE OF THE SEPARATION AND POSSIBLE BRITTLENESS/DEGRADATION OF THE CATHETER AND HUB'S MATERIALS COULD NOT BE CONCLUSIVELY DETERMINED. CONTROLS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY, REFER TO MANUFACTURING WORK INSTRUCTIONS (B)(4). NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME, GIVEN THAT THERE IS NO INDICATION THAT THE REPORTED ISSUE COULD BE RELATED TO THE MANUFACTURING PROCESS. THE COMPLAINT OF CRACKED PRIOR TO USE WAS CONFIRMED ON ANALYSIS; HOWEVER, THE EXACT CAUSE OF THE CONFIRMED FAILURE COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. REVIEW OF THE INFORMATION DOES NOT SUGGEST WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    TWO TEMPO GUIDING CATHETERS WERE BROKEN/CRACKED. WHEN THE PHYSICIAN OPENED THE PACKAGE, HE FOUND ONE CATHETER TIP WAS NEARLY BROKEN AND THE OTHER CATHETER TIP WAS CRACKED. THE PRODUCT S WILL BE RETURNED FOR INVESTIGATION. THE PRODUCTS HAD NOT BEEN COMPLETELY REMOVED FROM THE PACKAGE. THERE WAS NO DAMAGE TO THE PRODUCT PACKAGE. THE DEVICE WAS NOT RE-PROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH TEMPO 5 DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 14003329

    Patients

    Seq Age Sex Outcome Treatment
    1