BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARMADA

    MDR report key: 16801048 · Received April 24, 2023

    Report

    Report Number
    2024168-2023-04265
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    October 31, 2024
    Report Date
    April 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT ¿ ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE DEVICES WERE NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORDS (ELHR), CORRECTIVE ACTION TRACKING SYSTEM FOR THE WEB (CATSWEB) DATABASE REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART/LOT NUMBERS WERE NOT REPORTED. THE REPORTED PATIENT EFFECTS OF DISSECTION, PSEUDOANEURYSM, PERFORATION OF VESSELS, OCCLUSION, HEMATOMA, HEMORRHAGE, AND EMBOLISM ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), ARMADA 35 / ARMADA 35 LONG LENGTH GLOBAL AS KNOWN PATIENT EFFECTS OF THE PROCEDURE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF EMBOLISM / EMBOLUS, PERFORATION OF VESSELS, HEMATOMA, HEMORRHAGE, VASCULAR DISSECTION, OBSTRUCTION/ OCCLUSION, PSEUDOANEURYSM, 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: (B)(4) REV B TITLED; POST MARKET CLINICAL FOLLOW-UP EVALUATION REPORT PERIPHERAL DILATATION CATHETER FAMILY PLEASE SEE ATTACHMENT FOR COMPLETE DETAILS. 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 DEVICES WERE NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART/LOT NUMBERS WERE NOT REPORTED. THE REPORTED PATIENT EFFECT OF DISSECTION, PSEUDOANEURYSM, PERFORATION OF VESSELS, OCCLUSION, HEMATOMA, HEMORRHAGE, AND EMBOLISM ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), ARMADA 35 / ARMADA 35 LONG LENGTH GLOBAL AS A KNOWN PATIENT EFFECT OF THE PROCEDURE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF EMBOLISM / EMBOLUS, PERFORATION OF VESSELS, HEMATOMA, HEMORRHAGE, VASCULAR DISSECTION, OBSTRUCTION/ OCCLUSION, PSEUDOANEURYSM, 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. 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

    THIS IS FILED FOR THE PATIENT EFFECTS: IT WAS REPORTED THROUGH A POST MARKET CLINICAL FOLLOW UP (PMCF) EVALUATION REPORT IDENTIFYING THE ARMADA 35 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
    1188227 ARMADA PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR INC. UNK ARMADA 35

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other