BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 5F INFINITI TL PIG145 110

    MDR report key: 3831677 · Received May 26, 2014

    Report

    Report Number
    9616099-2014-00344
    Event Type
    Malfunction
    Date Received
    May 26, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE BEGINNING OF A CASE THE NURSE NOTED THAT A 5F PIGTAIL DIAGNOSTIC CATHETER ¿COMES OFF DURING THE PROCEDURE¿. NO ADDITIONAL INFORMATION IS AVAILABLE. PRELIMINARY VISUALIZATION UPON DEVICE RETURN FOUND THAT THERE WAS A ¿BEND¿ 10CM FROM THE DISTAL END. A NON-STERILE CATH F5 INF PIG145 110 CM 6SH .038¿ DIAGNOSTIC CATHETER WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE CATHETER WAS RECEIVED BENT AT 100 CM FROM HUB. NO SEPARATION WAS NOTED. ALSO, THE RECEIVED UNIT WAS VISUALLY INSPECTED UNDER VISION SYSTEM AND FOREIGN MATTER/ FIBER WAS OBSERVED FIRMLY LODGED IN THE FUSION AREA OF UNIT. NO OTHER ANOMALIES OBSERVED. THE OD AND ID WERE MEASURED NEAR TO THE BENT AREA AND RESULTS WERE FOUND WITHIN SPECIFICATION. FUNCTIONAL ANALYSIS WAS NOT CONDUCTED DUE TO ANY STERILE UNITS RETURNED TO PERFORM PULL TEST /ANALYSIS. A VERIFICATION FOR UNITS ON INVENTORY AS TO SUPPORT ANALYSIS RESULTS WAS REQUESTED TO MASTER PLANNER AND NO UNITS ON INVENTORY WERE FOUND. A CROSS-SECTION ANALYSIS WAS PERFORMED ON THE RECEIVED UNIT TO VISUALLY INSPECT THE FUSE AREA AND NO ANOMALIES OBSERVED. SEM AND EDS ANALYSIS WAS PERFORMED TO THE RECEIVED UNIT WITH THE FOLLOWING RESULTS: RESULTS SHOWED THAT THE UNKNOWN FILAMENTS ARE A COMPLETELY DIFFERENT MATERIAL COMPOSITION THAN THE BODY / SHAFT. AT THIS POINT IT COULD NOT BE DETERMINED THE TYPE OF MATERIAL OF FILAMENTS OBSERVED. THE FUSION OF THE BODY WITH THE TIP WAS ANALYZED WITH NO ANOMALIES FOUND. 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. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿DIAGNOSTIC CARDIOLOGY CATHETER-CATHETER (BODY/SHAFT) - SEPARATED-PRIOR TO USE¿ WAS NOT CONFIRMED SINCE THE CATHETER WAS NOT SEPARATED UPON RECEIPT. THE CATHETER WAS CONFIRMED TO BE KINKED TOWARD THE DISTAL END OF THE SHAFT. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, SHIPPING/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE KINKED/BENT CONDITION OF THE CATHETER AS THIS CONDITION WAS NOT NOTED BY THE CUSTOMER AT THE TIME OF USE. ADDITIONALLY, MICROSCOPIC VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED FOREIGN MATTER/FIBER FIRMLY LODGED IN THE FUSION AREA OF UNIT. EVEN THOUGH THE EXACT CAUSE OF THE FOREIGN MATTER/ FIBER CONTAMINATION FOUND ON THE DIAGNOSTIC CATHETER COULD NOT BE CONCLUSIVELY DETERMINED, THIS MAY BE MANUFACTURING RELATED. A RISK ASSESSMENT HAS BEEN INITIATED TO FURTHER EVALUATE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    (B)(4). UPDATED COMPLAINT CONCLUSION: IN THE BEGINNING OF A CASE THE NURSE NOTED THAT A 5F PIGTAIL DIAGNOSTIC CATHETER ¿COMES OFF DURING THE PROCEDURE¿. NO ADDITIONAL INFORMATION IS AVAILABLE. PRELIMINARY VISUALIZATION UPON DEVICE RETURN FOUND THAT THERE WAS A ¿BEND¿ 10CM FROM THE DISTAL END. A NON-STERILE CATH F5 INF PIG145 110 CM 6SH .038¿ DIAGNOSTIC CATHETER WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE CATHETER WAS RECEIVED BENT AT 100 CM FROM HUB. NO SEPARATION WAS NOTED. ALSO, THE RECEIVED UNIT WAS VISUALLY INSPECTED UNDER VISION SYSTEM AND FOREIGN MATTER/ FIBER WAS OBSERVED FIRMLY LODGED IN THE FUSION AREA OF UNIT. NO OTHER ANOMALIES OBSERVED. THE OD AND ID WERE MEASURED NEAR TO THE BENT AREA AND RESULTS WERE FOUND WITHIN SPECIFICATION. FUNCTIONAL ANALYSIS WAS NOT CONDUCTED DUE TO ANY STERILE UNITS RETURNED TO PERFORM PULL TEST /ANALYSIS. A VERIFICATION FOR UNITS ON INVENTORY AS TO SUPPORT ANALYSIS RESULTS WAS REQUESTED TO MASTER PLANNER AND NO UNITS ON INVENTORY WERE FOUND. A CROSS-SECTION ANALYSIS WAS PERFORMED ON THE RECEIVED UNIT TO VISUALLY INSPECT THE FUSE AREA AND NO ANOMALIES OBSERVED. SEM AND EDS ANALYSIS WAS PERFORMED TO THE RECEIVED UNIT WITH THE FOLLOWING RESULTS: RESULTS SHOWED THAT THE UNKNOWN FILAMENTS ARE A COMPLETELY DIFFERENT MATERIAL COMPOSITION THAN THE BODY / SHAFT. AT THIS POINT IT COULD NOT BE DETERMINED THE TYPE OF MATERIAL OF FILAMENTS OBSERVED. THE FUSION OF THE BODY WITH THE TIP WAS ANALYZED WITH NO ANOMALIES FOUND. 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. THE COMPLAINT REPORTED BY THE CUSTOMER AS ¿DIAGNOSTIC CARDIOLOGY CATHETER-CATHETER (BODY/SHAFT) - SEPARATED¿ WAS NOT CONFIRMED SINCE THE CATHETER WAS NOT SEPARATED UPON RECEIPT. THE CATHETER WAS CONFIRMED DURING ANALYSIS TO BE KINKED TOWARD THE DISTAL END OF THE SHAFT. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, SHIPPING/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE KINKED/BENT CONDITION OF THE CATHETER AS THIS CONDITION WAS NOT NOTED BY THE CUSTOMER AT THE TIME OF USE. ADDITIONALLY, MICROSCOPIC VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED FOREIGN MATTER/FIBER FIRMLY LODGED IN THE FUSION AREA OF UNIT. EVEN THOUGH THE EXACT CAUSE OF THE FOREIGN MATTER/ FIBER CONTAMINATION FOUND ON THE DIAGNOSTIC CATHETER COULD NOT BE CONCLUSIVELY DETERMINED, THIS MAY BE MANUFACTURING RELATED. A RISK ASSESSMENT HAS BEEN INITIATED TO FURTHER EVALUATE THIS ISSUE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICTED THAT A "5F DIAGNOSTIC CATHETER PIGTAIL COMES OFF DURING THE PROCEDURE." THE PRELIMINARY COMMENTS FROM CG LABS INDICATES ¿BEND AT 10CM FROM DISTAL.¿ ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP INDICATED HE NURSE WHO WAS IN THE PROCEDURE INDICATED THAT THE CATHETER GOT BROKEN IN THE BEGINNING OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309966 CATH 5F INFINITI TL PIG145 110 DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 16052904

    Patients

    Seq Age Sex Outcome Treatment
    1