BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARMADA

    MDR report key: 16812183 · Received April 25, 2023

    Report

    Report Number
    2024168-2023-04327
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    October 31, 2024
    Report Date
    April 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LIT
    PMA / PMN Number
    K121352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT ¿ ESTIMATED D4: THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICES WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF HEMATOMA, HEMORRHAGE, PERFORATION, OCCLUSION, PSEUDOANEURYSM, DISSECTION AND EMBOLISM ARE LISTED IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, ARMADA 14 XT, OTW, GLOBAL, INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS. THE INVESTIGATION DETERMINED THE REPORTED SERIOUS INJURY/ ILLNESS/ IMPAIRMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ADDITIONALLY, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF HEMATOMA, HEMORRHAGIC, PERFORATION, OCCLUSION, PSEUDOANEURYSM, DISSECTION AND EMBOLISM AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ATTACHMENT: RPT2135004 REV B TITLED; POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT PERIPHERAL DILATATION CATHETER FAMILY AS MULTIPLE DEVICES WERE CAPTURED IN THE PMCF REPORT, THE OTHER DEVICES REFERENCED IN THE PMCF ARE FILED UNDER SEPARATE REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED INFLATION ISSUE, DEFLATION ISSUE AND PATIENT-DEVICE INCOMPATIBILITY; HOWEVER, THE REPORTED SERIOUS INJURY/ ILLNESS/ IMPAIRMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ADDITIONALLY, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) OF HEMATOMA, HEMORRHAGIC, PERFORATION, OCCLUSION, PSEUDOANEURYSM, DISSECTION AND EMBOLISM AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. B3 REVISED: DATE OF EVENT ESTIMATED AS 10/31/2024 - BASED UPON DATA REPORTED DURING THE TIME FRAME OF 09/19 - 10/31/2024. D4: THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. CORRECTIONS: D1 ¿ BRAND NAME: UPDATED. D2A - COMMON DEVICE NAME: UPDATED. D3 ¿ NAME, ADDRESS 1, CITY, POSTAL CODE: UPDATED. D4 - PRIMARY UDI NUMBER: UPDATED FROM NI TO UNKNOWN. E1 - TITLE: UPDATED FROM UNK TO DR. E3 - OCCUPATION: UPDATED FROM NA TO PHYSICIAN. ATTACHMENT: RPT2135004 REV C TITLED: POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT PERIPHERAL DILATATION CATHETER FAMILY. AS MULTIPLE DEVICES WERE CAPTURED IN THE PMCF REPORT, THE OTHER DEVICES REFERENCED IN THE PMCF ARE FILED UNDER SEPARATE REPORT NUMBERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A POST MARKET CLINICAL FOLLOW UP (PMCF) EVALUATION REPORT IDENTIFYING THE ARMADA 14 XT DILATATION CATHETER THAT MAY BE RELATED TO THE FOLLOWING: ADVERSE EFFECTS OF VESSEL RUPTURE/HEMORRHAGIC EVENT, DISSECTION, PERFORATION, HEMATOMA, EMBOLISM, OCCLUSION/ABRUPT CLOSURE, PSEUDOANEURYSM, AND DEVICE ISSUES OF INFLATION AND DEFLATION ISSUES, AND INABILITY TO POST-DILATE A STENT. DETAILS ARE LISTED IN THE ATTACHED PMCF, TITLED POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT PERIPHERAL DILATATION CATHETER FAMILY PLEASE SEE THE ATTACHED POST MARKET CLINICAL FOLLOW UP EVALUATION REPORT FOR SPECIFIC INFORMATION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORTS, ADDITIONAL INFORMATION WAS RECEIVED THAT THE SAME DATA POINTS WERE CAPTURED VIA AN UPDATE TO THIS POST MARKET CLINICAL FOLLOW-UP (PMCF) EVALUATION REPORT PERIPHERAL DILATATION CATHETER FAMILY. DATA WAS COLLECTED BETWEEN SEPTEMBER 19, 2024, AND OCTOBER 31, 2024. PLEASE SEE THE ATTACHED PMCF EVALUATION REPORT FOR SPECIFIC INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865699 ARMADA CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT ABBOTT VASCULAR INC. UNK ARMADA 14 XT OTW

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other