BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS VIKING CORONARY GUIDING CATHETER

    MDR report key: 1215423 · Received October 27, 2008

    Report

    Report Number
    2024168-2008-00314
    Event Type
    Malfunction
    Date Received
    October 27, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DRA
    PMA / PMN Number
    K001435
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDING CATHETER WAS RETURNED WITHOUT BLOOD OR CONTRAST VISIBLE. THE GUIDING CATHETER WAS RETURNED WITH THE PACKAGING UNOPENED. THE PACKAGING LABEL WAS 6F ALR 1.2. THE TIP OF THE GUIDING CATHETER MATCHES THE TEMPLATE FOR A LEFT BYPASS. THE LABEL ON THE LUER WAS A 6F BYPASS LEFT. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDING CATHETER. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE CASE DESCRIPTION AND THE ANALYSIS OF THE RETURNED DEVICES. IT WAS REPORTED THAT THE REPLACEMENTS THIS ACCOUNT RECEIVED. ALSO HAD THE WRONG GUIDING CATHETERS INSIDE. THERE ARE FOUR DEVICES INVOLVED IN THIS COMPLAINT. ANALYSIS OF THE DEVICES WAS ABLE TO CONFIRM THE COMPLAINT. THE GUIDING CATHETERS WERE RETURNED WITH THE PACKAGE UNOPENED. ALL PACKAGING LABELS WERE 6F ALR 1.2, AND THE LABELS ON THE LUERS WERE A 6F BYPASS LEFT. ADDITIONALLY, THE TIP SHAPE OF THE GUIDING CATHETERS MATCHED THE TEMPLATE FOR LEFT BYPASS. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDING CATHETERS. MANUFACTURING RECORDS 01/17/2008, SHOWED ONE LOT OF EACH PART NUMBER, 1001970-06 (6F VIKING BP-L) AND 1001934-06 (6F VIKING ALR1.2) WITH THE SAME LOT NUMBER WERE MANUFACTURED THAT DAY. COMPLAINT INFORMATION INDICATES THE FOLLOWING INCIDENTS INVOLVING A TOTAL OF 11 GUIDING CATHETERS FOR PN 1001934-06 (6F VIKING ALR 1.2), OR PN 1001970-06 (6F VIKING BP-L), LN 8011791 (EXCEPT INCIDENT LN UNKNOWN) REPORTING THE WRONG CATHETER WAS INCLUDED IN THE PACKAGING. SINCE AN ISSUE HAS BEEN REPORTED WITH BOTH LOTS, AND SOME DEVICES WERE RECEIVED SEALED FOR ANALYSIS AND CONFIRMED AS A WRONG SHAPE, THIS DOES NOT APPEAR TO BE A MIX UP AT THE ACCOUNT, BUT AT THE MANUFACTURING LINE. THE BUSINESS UNIT WILL BE NOTIFIED OF THE OCCURRENCES. ALL CATHETERS ARE SUBJECTED TO 100% VISUAL INSPECTION BY MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY PRODUCT QUALITY. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: PRODUCT RECALL. DEVICE ISSUE: MISLABELED. IT WAS REPORTED THAT THE DEVICE DID NOT MATCH THE LABEL. THE PACKAGING WAS LABELED WITH THE 6FR VIKING- BY PASS LEFT GUIDE. THE DEVICE WAS NOT USED ON THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THIS IS BEING REPORTED BASED ON A PRODUCT MALFUNCTION; MISLABELED PACKAGING, THAT LEAD THE COMPANY TO INITIATE A CORRECTION AND REMOVAL ACTIVITY ON MARCH 18, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS VIKING CORONARY GUIDING CATHETER 74DRA DRA ABBOTT VASCULAR-CARDIAC THERAPIES NA 8011791

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK