BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PRODUCT - CORDIS CORPORATION

    MDR report key: 16404157 · Received February 20, 2023

    Report

    Report Number
    9616099-2023-06264
    Event Type
    Injury
    Date Received
    February 20, 2023
    Date of Event
    December 13, 2022
    Report Date
    March 8, 2023
    Manufacturer
    CORDIS US. CORP
    Product Code
    DYB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO REPORT # 3009018440-2023-00025. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. INFORMATION IS LIMITED DUE TO BEING A SURVEY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO REPORT # 3009018440-2023-00025. NON-COMPLAINT RATIONALE: IT WAS REPORTED BY A SURVEY RESPONDENT THERE WAS THROMBUS WHICH RESOLVED AFTER REPEAT INJECTION. A SABER .035 4MM X 4CM WAS USED FOR THE AV FISTULA PROCEDURE. THE LESION WAS NOTED TO BE 1-2MM IN LENGTH. THE LESION HAD A 50-75% STENOSIS. A 5F CORDIS SHEATH WAS USED WITH A NON-CORDIS 80 CM GUIDEWIRE. IT WAS REPORTED BY A SURVEY RESPONDENT THERE WAS THROMBUS WHICH RESOLVED AFTER REPEAT INJECTION. NO OTHER DETAILS WERE PROVIDED, AND NO DEVICE MALFUNCTION WAS REPORTED. THE SABER035TM PTA CATHETER IS INTENDED TO DILATE STENOSES IN ILIAC, FEMORAL, ILIO-FEMORAL, POPLITEAL, INFRA POPLITEAL, AND RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. THE DEVICE IS ALSO INDICATED FOR POST-DILATION OF BALLOON-EXPANDABLE AND SELF-EXPANDING STENTS IN THE PERIPHERAL VASCULATURE. PTA BALLOONS AIDE IN THE TREATMENT OF PRE-EXISTING DISEASE AND PROGRESSIVE DISEASE STATES BY TEMPORARILY DILATING A VESSEL. BECAUSE THEY ARE NOT IMPLANTED, THEY ARE NOT INTENDED FOR LONG TERM PATENCY OF A VESSEL. A THROMBUS, COLLOQUIALLY CALLED A BLOOD CLOT, IS THE FINAL PRODUCT OF THE BLOOD COAGULATION STEP IN HEMOSTASIS. THERE ARE TWO COMPONENTS TO A THROMBUS: AGGREGATED PLATELETS AND RED BLOOD CELLS THAT FORM A PLUG, AND A MESH OF CROSS-LINKED FIBRIN PROTEIN. HOWEVER, A CLOT CAN FORM MORE EASILY WHEN A PERSON HAS MULTIPLE COMORBIDITIES SUCH AS TOBACCO USE, HIGH CHOLESTEROL, OBESITY, CANCER, DIABETES, ATRIAL FIBRILLATION, AND LIVES A SEDENTARY LIFESTYLE. SOME OF THESE FACTORS ALSO INCREASE THE RISK OF ATHEROSCLEROSIS, A CONDITION WHEREIN FATTY PLAQUE DEPOSITS LINE THE BLOOD VESSELS INHIBITING BLOOD FLOW. ADDITIONALLY, WE DO NOT KNOW WHAT THE ANTICOAGULANT/ANTIPLATELET STATUS OF THE PATIENT WAS AT THE TIME OF THE EVENT AS THIS INFORMATION WAS NOT PROVIDED. IT IS UNCLEAR WHAT THE RELATION OF THE THROMBUS IS TO THE SABER035 PTA BALLOON CATHETER. CLARIFICATION OF THE EVENT WAS REQUESTED, AND ADDITIONAL INFORMATION REVEALED THERE WAS NO REPORTED THROMBUS OR MALFUNCTION RELATED TO THE SABER035 PTA BALLOON CATHETER, SPECIFICALLY STATING THE PHYSICIAN ¿DIDN¿T DISCUSS OR SUBMIT A COMPLAINT¿. THEREFORE, THERE IS NO MEDICAL EVIDENCE TO SUGGEST THAT THE PTA BALLOON CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS SUCH, THIS INFORMATION WILL BE CAPTURED IN A NON-COMPLAINT AND PROCESSED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED, THERE WAS THROMBUS WHICH RESOLVED AFTER REPEAT INJECTION. A SABER .035 4MM X 4CM WAS USED FOR THE AV FISTULA PROCEDURE. THE LESION WAS NOTED TO BE 1-2MM IN LENGTH. THE LESION HAD A 50-75% STENOSIS. A 5F CORDIS SHEATH WAS USED WITH A NON-CORDIS 80 CM GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408028 UNK - PRODUCT - CORDIS CORPORATION INTRODUCER, CATHETER DYB CORDIS US. CORP UNK - PRODUCT - CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O 5F CORDIS SHEATH| TERUMO GUIDEWIRE 80CM