BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS VIKING CORONARY GUIDING CATHETER

    MDR report key: 1032395 · Received April 17, 2008

    Report

    Report Number
    2024168-2008-00302
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    February 24, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DYB
    PMA / PMN Number
    K001435
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE GUIDING CATHETER WAS RETURNED WITH BLOOD VISIBLE ON THE LUER. THERE WAS NO CONTRAST VISIBLE. THERE WAS A KINK IN THE SHAFT 60 CM DISTAL TO THE BASE OF THE LUER. THE LABEL ON THE GUIDING CATHETER WAS 6F VIKING .066 ID ALR 1.2, WHICH IS AN AMPLATZ LEFT RIGHT GUIDING CATHETER. THE PACKAGING LABEL WAS A 6F VIKING .066" BYPASS LEFT GUIDING CATHETER. THE TIP OF THE GUIDING CATHETER WAS COMPARED TO THE LEFT BYPASS AND ALR 1.2 TEMPLATE. THE TIP OF THE GUIDING CATHETER MATCHES THE ALR 1.2 TEMPLATE. THERE WAS NO OTHER DAMAGE NOTED TO THE GUIDING CATHETER. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE CASE DESCRIPTION, AND THE ANALYSIS OF THE RETURNED DEVICE. IT WAS REPORTED THAT THE DEVICE DID NOT MATCH THE PACKAGING LABEL. THE PACKAGING WAS LABELED WITH THE 6FR VIKING BY PASS LEFT GUIDE; HOWEVER, DURING INSERTION, IT WAS DISCOVERED TO BE A DIFFERENT DEVICE, NOT WHAT WAS REFERENCED ON THE PACKAGING. ANALYSIS OF THE RETURNED DEVICE WAS ABLE TO CONFIRM THE COMPLAINT AS THE DEVICE WAS LABELED AS A 6F VIKING .066 ID ALR 1.2. ADDITIONALLY, COMPARISON OF THE TIP SHAPE TO THE VISUAL QUALITY STANDARD CONFIRMED THE SHAPE AS AN ALR 1.2. MANUFACTURING RECORDS FOR 01/17/08 SHOWED ONE LOT OF EACH PART NUMBER, 1001970-06 (6F VIKING BP-L) AND 1001934-06 (6F VIKING APR 1.2) WITH THE SAME LOT NUMBER WERE MANUFACTURED THAT DAY. COMPLAINT INFO INDICATES THE INCIDENTS INVOLVING A TOTAL OF 11 GUIDING CATHETERS FOR PART# 1001934-06 (6F VIKING ALR 1.2), OR PART #1001970-6 (6F VIKING BP-L), LOT# 8011791 WITH THE EXCEPTION OF INCIDENT 103934 WITH LOT# UNKNOWN) REPORTING THAT 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 A MANUFACTURING ISSUE. THE BUSINESS UNIT WILL BE NOTIFIED OF THE OCCURRENCES. ANALYSIS OF THE DEVICE ALSO FOUND A KINK OF THE SHAFT OF THE GUIDING CATHETER. DAMAGE TO THE SHAFT OF THE GUIDING CATHETER CAN BE DUE, BUT NOT LIMITED TO, MANUFACTURING, TRANSPORTATION, STORAGE, HANDLING, USER TECHNIQUE, DEVICE SELECTION, PATIENT LESION MORPHOLOGY/ANATOMY, OR TRANSPORTATION BACK TO ABBOT VASCULAR FOR ANALYSIS. IN THIS INSTANCE A ROOT CAUSE FOR THE KINK CANNOT BE DETERMINED, HOWEVER, IT IS NOT RELATED OR CONTRIBUTED TO THE REPORTED ISSUE. 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 WITH THE 6FR VIKING-BY PASS LEFT GUIDE; HOWEVER, DURING INSERTION, IT WAS DISCOVERED TO BE A DIFFERENT DEVICE THAN WAS REFERENCED ON THE PACKAGING. NO PT EFFECTS REPORTED. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE. THIS IS BEING REPORTED BASED ON A PRODUCT MALFUNCTION, MISLABELED PACKAGING, THAT LEAD THE CO 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 DYB ABBOTT VASCULAR-CARDIAC THERAPIES NA 8011791

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK