BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEL BIPOLAR PACING CATHETER

    MDR report key: 15542632 · Received October 5, 2022

    Report

    Report Number
    2182269-2022-00040
    Event Type
    Injury
    Date Received
    October 5, 2022
    Report Date
    February 14, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LDF
    PMA / PMN Number
    K152784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC TAMPONADE REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PATIENT ISSUES REMAINS UNKNOWN.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, IN AN ARTICLE ENTITLLED: TCT-464 REDUCING CARDIAC TAMPONADE CAUSED BY TEMPORARY PACEMAKER PERFORATION IN TRANSCATHETER AORTIC VALVE REPLACEMENT, SUPPL. SUPPLEMENT 80.12: B187. ELSEVIER INC " DALEN, MAGNUS MD. THIS WAS A SINGLE-CENTER REGISTRY OF ALL CONSECUTIVE TRANSFEMORAL TAVRS PERFORMED IN 2014 TO 2020. THE MAIN INCLUSION CRITERION WAS THE USE OF A TEMPORARY PACING LEAD FOR PERI-INTERVENTIONAL PACING. THE MAIN EXCLUSION CRITERION WAS THE NONUSE OF A TEMPORARY PACING LEAD, SUCH AS A PREOPERATIVELY IMPLANTED PERMANENT PACEMAKER OR LEFT VENTRICULAR GUIDEWIRE PACING ONLY. CASES OF CARDIAC TAMPONADE WERE CLASSIFIED AS PACEMAKER LEAD RELATED, LEFT VENTRICULAR WIRE RELATED, OR ANNULAR RUPTURE RELATED. PATIENTS WERE GROUPED BASED ON THE TYPE OF PERI-OPERATIVE PACING WIRE USED. TWO EVENTS OF CARDIAC TAMPONADE / PERFORATION OCCURRED DUE TO LEFT VENTRICULAR WIRE PERFORATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, IN AN ARTICLE ENTITLED: TCT-464 REDUCING CARDIAC TAMPONADE CAUSED BY TEMPORARY PACEMAKER PERFORATION IN TRANSCATHETER AORTIC VALVE REPLACEMENT, SUPPL. SUPPLEMENT 80.12: B187. ELSEVIER INC " DALEN, MAGNUS MD. THIS WAS A SINGLE-CENTER REGISTRY OF ALL CONSECUTIVE TRANSFEMORAL TAVRS PERFORMED IN 2014 TO 2020. THE MAIN INCLUSION CRITERION WAS THE USE OF A TEMPORARY PACING LEAD FOR PERI-INTERVENTIONAL PACING. THE MAIN EXCLUSION CRITERION WAS THE NONUSE OF A TEMPORARY PACING LEAD, SUCH AS A PREOPERATIVELY IMPLANTED PERMANENT PACEMAKER OR LEFT VENTRICULAR GUIDEWIRE PACING ONLY. CASES OF CARDIAC TAMPONADE WERE CLASSIFIED AS PACEMAKER LEAD RELATED, LEFT VENTRICULAR WIRE RELATED, OR ANNULAR RUPTURE RELATED. PATIENTS WERE GROUPED BASED ON THE TYPE OF PERI-OPERATIVE PACING WIRE USED. IN TOTAL, 18 (2.2%) EVENTS OF CARDIAC TAMPONADE OCCURRED, 12 (67%) WERE PACEMAKER LEAD RELATED. ALL PACEMAKER LEAD-RELATED CARDIAC TAMPONADES OCCURRED IN THE GROUP WHO RECEIVED A STANDARD RV-TPW AND NONE IN THE GROUP WHO RECEIVED RV-TPPL (N¿=¿12 [2.1%] VS. N¿=¿0 [0%], P¿=¿0.022). NO DIFFERENCE IN CARDIAC TAMPONADE DUE TO OTHER CAUSES WAS SEEN BETWEEN THE GROUPS (P¿=¿0.82). TWO EVENTS (11%) OF CARDIAC TAMPONADE / PERFORATION OCCURRED DUE TO LEFT VENTRICULAR WIRE PERFORATION REQUIRING PERICARDIOCENTESIS. TWO EVENTS (0.4%) OF DEATH RELATED TO RV PACING COMPLICATIONS. ONE EVENT (0.2%) OF PERIOPERATIVE MYOCARDIAL INFARCTION. TWELVE EVENTS (2.2%) OF POSTOPERATIVE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555070 PACEL BIPOLAR PACING CATHETER TEMPORARY CARDIAC PACING BALLOON CATHETER LDF ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R