BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP SINGLE STAGE VENOUS CANNULA

    MDR report key: 2964352 · Received February 15, 2013

    Report

    Report Number
    2184009-2013-00006
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    March 21, 2012
    Report Date
    March 26, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DWF
    PMA / PMN Number
    K842375
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE SUBMISSION OF THE INITIAL MEDWATCH REPORT, OUR INVESTIGATION WAS COMPLETED. THIS SUPPLEMENTAL REPORT IS TO PROVIDE YOU WITH OUR FINAL INVESTIGATION FINDINGS AND CORRECTED CODING. INVESTIGATION: TWO DEVICES WERE RETURNED TO MEDTRONIC; BOTH DEVICES APPEARED TO HAVE BEEN USED. BASED ON THESE FINDINGS, IT IS BELIEVED THAT ONE DEVICE WAS USED FOR THE ORIGINAL CANNULATION WHICH RESULTED IN THE VESSEL PERFORATIONS, AND THE SECOND RETURNED DEVICE WAS THE REPLACEMENT DEVICE. HOWEVER, NEITHER DEVICE WAS LABELED AS SUCH, THUS MEDTRONIC IS UNABLE TO DETERMINE WHICH SPECIFIC DEVICE WAS BEING USED AT THE TIME WHEN THE PERFORATIONS OCCURRED. NO ANOMALIES (I.E. PRESENCE OF FIBRIN) WERE NOTED DURING INITIAL INSPECTION OF THE RETURNED DEVICES. FOLLOWING DECONTAMINATION OF THE DEVICES, A VISUAL INSPECTION UNDER MAGNIFICATION IDENTIFIED A ROUGH SURFACE FINISH ALONG THE SIDE HOLES OF THE METAL TIPS. THE SIDE HOLES ARE MADE VIA AN ELECTRICAL DISCHARGE MACHINING (EDM) PROCESS, AND THE ROUGH SURFACE ALONG THE SIDE HOLES OF THE COMPLAINT DEVICES IS A KNOWN OUTPUT OF THE EDM PROCESS. THE APPEARANCE OF THE COMPLAINT DEVICES IS NO DIFFERENT THAN OTHER METAL TIPS REVIEWED DURING INVESTIGATION OF THIS ISSUE. NO "SERRATED EDGES" WERE NOTED ON TH E DEVICE AS ALLEGED BY THE CUSTOMER. THE ROUGH SURFACE FINISH BY ITSELF IS HIGHLY UNLIKELY TO CAUSE VESSEL PERFORATION; THIS IS EVIDENT BY THE LACK OF COMPLAINTS FOR VESSEL DAMAGE ASSOCIATED WITH METAL TIP VENOUS CANNULA. THE USE OF VACUUM ASSISTED DRAINAGE, WHICH WAS UTILIZED WITH THE COMPLAINT DEVICE, COULD POTENTIALLY EXACERBATE THE RISK OF VESSEL DISSECTION, ESPECIALLY IF THE CANNULA TIP RESTS ALONG THE WALL OF THE SVC AND VEIN TISSUE IS SUCKED INTO THE INNER DIAMETER OF THE CANNULA. ULTIMATELY, ROOT CAUSE OF THE VESSEL DAMAGE HAS NOT BEEN IDENTIFIED. THIS EVENT IS CONSIDERED AN ISOLATED INCIDENT. MEDTRONIC WILL CONTINUE TO MONITOR THE COMPLAINT DATABASE FOR SIMILAR OCCURRENCES; HOWEVER NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE DEVICE WAS OBSERVED UNDER MAGNIFICATION AND THERE WERE SOME ROUGH EDGES NOTED IN THE SIDE HOLES. CONCLUSION: ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATION. BASED ON THE INFORMATION PROVIDED AND ANALYSIS RESULTS, WE SUSPECT THE ROUGH SURFACE FINISH ALONG THE SIDE PORTS, COUPLED WITH THE SUCTION APPLIED DURING THE CASE MAY HAVE CONTRIBUTED TO THE EVENT. CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN IMPLEMENTED AT THE SUB SUPPLIER TO SMOOTH OUT THE EDGES AROUND THE METAL TIP HOLES OF THE CANNULA. THIS DEVICE WAS MANUFACTURED PRIOR TO THE CORRECTIVE AND PREVENTATIVE ACTIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT MIDWAY INTO AN INTRACARDIAC SURGICAL PROCEDURE (APPROXIMATELY HALF-HOUR AFTER THE CANNULA WAS INSERTED) THIS VENOUS CANNULA WITH METAL TIP PERFORATED THE UPPER PART OF THE SUPERIOR VENA CAVA (SVC) NEAR THE CONFLUENCE WITH THE BRACHIOCEPHALIC VEIN. THERE WERE THREE PERFORATIONS, EACH APPROXIMATELY THREE MM IN DIAMETER, RESULTING IN UNEXPECTED BLEEDING FROM THE SVC. IT WAS OBSERVED THAT THE SERRATED EDGES OF THE METAL TIP OF THE VENOUS CANNULA CUT THROUGH THE VESSEL WALL. THE REMNANTS OF THE THYMUS GLAND ABOVE THE SVC SUDDENLY SWELLED WITH HEMATOMA. AFTER THE THYMUS GLAND WAS REMOVED, IT WAS EVIDENT THAT THERE WAS BLEEDING FROM THE SVC. AS CARDIOPULMONARY BYPASS WAS PERFORMED WITH SOME NEGATIVE SUCTION ON THE VENOUS SIDE (FAIRLY ROUTINE IN PEDIATRIC CASES) IT ACCELERATED THE SAW-LIKE EFFECT OF THE SERRATED CANNULA TIP EDGE. THE CANNULA WAS REPLACED AND THE VESSEL WAS REPAIRED WITH DIRECT SUTURE. THE POSTOPERATIVE COURSE WAS NORMAL WITH NO ADVERSE PATIENT AFFECT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68165 DLP SINGLE STAGE VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF MEDTRONIC, INC. 67320 2011110483

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R