BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS VIKING CORONARY GUIDING CATHETER

    MDR report key: 1215430 · Received October 27, 2008

    Report

    Report Number
    2024168-2008-00308
    Event Type
    Malfunction
    Date Received
    October 27, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 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
    PHYSICIAN

    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 LABEL ON THE LUER WAS A 6F BYPASS LEFT. THE TIP OF THE GUIDING CATHETER MATCHES THE TEMPLATE FOR A LEFT BYPASS. THERE WAS NO 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 DEVICES DID NOT MATCH THE PACKAGING LABELS. THE PACKAGING WAS LABELED ALR 1.2, BUT THE DEVICES INSIDE THE PACKAGES WERE BYPASS LEFT GUIDE CATHETERS. THERE ARE FOUR DEVICES INVOLVED IN THIS COMPLAINT. ANALYSIS OF THE DEVICES WAS ABLE TO CONFIRM THE COMPLAINT. ONE OF THE DEVICES WAS NOT RETURNED, BUT THE PACKAGING WAS LABELED AS A 6F VIKING .066 ID ALR 1.2. IN THE CASE OF ALL OTHER 3 DEVICES, 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 A LEFT BYPASS. THERE WAS NO DAMAGE NOTED TO THE GUIDING CATHETERS. MANUFACTURING RECORDS FOR 01/17/2008, SHOWED ONE LOT OF EACH PART NUMBER, 1001970-06 (6F VIKING BP-L) AND 1001934-06 (6F VIKING ALR 1.2) WITH THE SAME LOT NUMBER WERE MANUFACTURED THAT DAY. COMPLAINT INFORMATION INDICATES THE FOLLOWING INCIDENTS INVOLVING A TOTAL OF 11 GUIDING CATHETERS FOR PART NUMBER 1001934-06 (6F VIKING ALR 1.2), OR PART NUMBER 1001970-06 (6F VIKING BP-L), LOT NUMBER 8011791 (EXCEPT INC WITH LOT NUMBER 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, 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. 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 PACKAGING LABEL. THE PACKAGING WAS LABELED ALR 1.2; HOWEVER, THE DEVICE INSIDE THE PACKAGE WAS A BYPASS LEFT GUIDE CATHETER. THE DEVICE WAS NOT USED ON A 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 IN 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