BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET

    MDR report key: 8902278 · Received August 16, 2019

    Report

    Report Number
    9680794-2019-00319
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 7, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DXE
    PMA / PMN Number
    K011056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED A 5FR PTD CATHETER FOR EVALUATION. THE PTD BASKET WAS FULLY ADVANCED FROM THE SHEATH AND DRIED BLOOD WAS OBSERVED ON THE CATHETER SHEATH. VISUAL EXAMINATION REVEALED THAT THE DISTAL END OF THE BLACK PEBAX TIP WAS SEPARATED AND NOT RETURNED. MICROSCOPIC EXAMINATION CONFIRMED THAT THE BLACK PEBAX TIP BROKE NEAR THE BASE OF THE DISTAL BASKET. THE TIP MATERIAL APPEARED JAGGED AND UNEVEN, INDICATING A STRESS RELATED TEAR. ALL THE BASKET WIRES WERE INTACT AND SECURED WITHIN THE BASKET CONNECTORS. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED WITH THE PTD ASSEMBLY. THE PEBAX TIP ADHERED TO THE BASKET MEASURED TO BE 0.118" WHICH INDICATES AT LEAST 0.3976" OF THE TIP WAS SEPARATED AND NOT RETURNED BASED ON SPECIFICATIONS OF 0.5156-0.5626" PER PRODUCT DRAWING. THE PTD BASKET WAS ABLE TO ADVANCE OR RETRACT FROM THE SHEATH WITH MINIMAL RESISTANCE. THE PTD CATHETER WAS PLACED INTO A LAB INVENTORY ROTATOR TO FUNCTIONALLY TEST, AND IT WAS ABLE TO ROTATE. NO FUNCTIONAL ISSUES WERE FOUND. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS PRODUCT STATES UNDER GENERAL WARNINGS THAT THE PTD DEVICE IS NOT FOR USE IN STENTS. IT PROVIDES INSTRUCTIONS IN THE EVENT THE BLACK FLEXIBLE BASKET TIP "FOLDS OVER" ITSELF AND WHILE IN USE, STATES THAT THE EXPOSED PORTION OF THE CATHETER IS TO BE KEPT STRAIGHT AT ALL TIMES TO AID IN SUCCESSFUL BASKET DEPLOYMENT. IT WARNS THAT THE ROTATING BASKET IS TO BE WITHDRAWN IN THE DEPLOYED POSITION PRIOR TO REACHING THE SHEATH AT A RECOMMENDED RATE OF 1-2CM/SECOND WHEN SHARP RADII IS ENCOUNTERED AND THAT THE CATHETER IS NOT TO BE ADVANCED FORWARD DURING ACTIVATION. IT ALSO WARNS THAT POTENTIAL FATIGUE FAILURE OF THE PTD CABLE AND FRAGMENTATION BASKET MAY OCCUR WITH PROLONGED ACTIVATION OF THE PTD DEVICE. THE IFU ALSO PROVIDES VARIOUS WARNINGS AND PRECAUTIONS FOR THE USER TO REEVALUATE TREATMENT OR TO CONSIDER ALTERNATIVE TREATMENTS IF THERE IS A PRESENCE OF VENOUS OUTFLOW STENOSIS GREATER THAN 10CM LONG, UNTREATABLE CONDITIONS OR LARGE PSEUD OANEURYSM. THE REPORT THAT THE PTD TIP WAS BROKEN DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. MICROSCOPIC EXAMINATION REVEALED THAT THE DISTAL END OF THE BLACK PEBAX TIP WAS BROKEN OFF. THE TIP MATERIAL APPEARED JAGGED AND UNEVEN, INDICATING A STRESS RELATED BREAKAGE. AN INCREASE IN THE OCCURRENCE RATE FOR PTD TIP SEPARATION COMPLAINTS HAS RESULTED IN A CAPA INVESTIGATION. THE MANUFACTURING PROCESS HAS NOT BEEN SHOWN AS A CAUSE AND THE SAMPLES HAVE MET THE TENSILE SPECIFICATION. THEREFORE, THE CAUSE OF THIS COMPLAINT IS UNDETERMINED.

    Description of Event or Problem · 0

    THE DOCTOR USED THE 5F PTD SYSTEM FOR THROMBECTOMY PROCEDURE, AND AFTER 1 PASS OF THE PTD, THE DOCTOR HEARD A "REVVING DOWN" OF THE PTD MOTOR/BASKET. THE DOCTOR THEN PULLED OUT THE ENTIRE PTD SYSTEM, AND NOTICED THAT A PIECE OF THE COVERED GRAFT WAS ON THE PTFE LINING OF THE BASKET. UNDER FLUORO, HE WAS ABLE TO SEE THE TIP OF THE PTD CATHETER EMBEDDED INTO THE WALL OF THE GRAFT AND SOFT TISSUE. THE DOCTOR ATTEMPTED TO SNARE THE TIP OUT, BUT HE REPORTED THAT IT WAS TOO EMBEDDED TO PULL OUT. THE DOCTOR THEN DEPLOYED A COVERED STENT GRAFT OVER THE TIP AND THE ABNORMALITIES OF THE GRAFT. THE DOCTOR SAID THAT HE BELIEVE THE ORIGINAL COVERED GRAFT WAS DEFECTIVE AND IT WAS NOT THE PTD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR USED THE 5F PTD SYSTEM FOR THROMBECTOMY PROCEDURE, AND AFTER 1 PASS OF THE PTD, THE DOCTOR HEARD A "REVVING DOWN" OF THE PTD MOTOR/BASKET. THE DOCTOR THEN PULLED OUT THE ENTIRE PTD SYSTEM, AND NOTICED THAT A PIECE OF THE COVERED GRAFT WAS ON THE PTFE LINING OF THE BASKET. UNDER FLUORO, HE WAS ABLE TO SEE THE TIP OF THE PTD CATHETER EMBEDDED INTO THE WALL OF THE GRAFT AND SOFT TISSUE. THE DOCTOR ATTEMPTED TO SNARE THE TIP OUT, BUT HE REPORTED THAT IT WAS TOO EMBEDDED TO PULL OUT. THE DOCTOR THEN DEPLOYED A COVERED STENT GRAFT OVER THE TIP AND THE ABNORMALITIES OF THE GRAFT. THE DOCTOR SAID THAT HE BELIEVE THE ORIGINAL COVERED GRAFT WAS DEFECTIVE AND IT WAS NOT THE PTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697157 ARROW PERCUTANEOUS THROMBOLYTIC DEVICE SET CATHETER EMBOLECTOMY DXE ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention