BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL

    MDR report key: 17213582 · Received June 27, 2023

    Report

    Report Number
    2029046-2023-01357
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    April 23, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: D¿ANGELO RN, KORJIAN S, D¿AVILA A, WAKS J, ENTRAPMENT OF HIGH-DENSITY GRID MAPPING CATHETER IN A PERCUTANEOUS VENTRICULAR ASSIST DEVICE PIGTAIL DURING VENTRICULAR TACHYCARDIA ABLATION WITH PERCUTANEOUS HEMODYNAMIC SUPPORT, HEARTRHYTHM CASE REPORTS (2023), DOI: HTTPS:// DOI.ORG/10.1016/J.HRCR.2023.04.014. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE LITERATURE ARTICLE FILE IS TOO LARGE TO ATTACH. MANUFACTURER'S REF #: (B)(4)

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: D¿ANGELO RN, KORJIAN S, D¿AVILA A, WAKS J, ENTRAPMENT OF HIGH-DENSITY GRID MAPPING CATHETER IN A PERCUTANEOUS VENTRICULAR ASSIST DEVICE PIGTAIL DURING VENTRICULAR TACHYCARDIA ABLATION WITH PERCUTANEOUS HEMODYNAMIC SUPPORT, HEARTRHYTHM CASE REPORTS (2023), DOI: HTTPS:// DOI.ORG/10.1016/J.HRCR.2023.04.014. CASE REPORT: A 50 YO MALE RECEIVED PLACEMENT OF A SINGLE CHAMBER IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND WAS STARTED ON GOAL-DIRECTED MEDIAL THERAPY FOR HEART FAILURE. HE HAD MULTIPLE EPISODES OF MONOMORPHIC VT, WHICH TERMINATED WITH ANTITACHYCARDIA PACING (ATP). HE WAS STARTED ON AMIODARONE, BUT DEVELOPED VT STORM TREATED WITH MULTIPLE SHOCKS FROM HIS ICD. HE WAS STARTED ON A LIDOCAINE DRIP AND ADMITTED TO THE CARDIAC ICU. GIVEN INCESSANT VT, HE WAS INTUBATED, SEDATED, AND UNDERWENT STELLATE GANGLION BLOCK IN PREPARATION FOR VT ABLATION. UNDER GENERAL ANESTHESIA, AN IMPELLA CP DEVICE PLACED VIA LEFT FEMORAL ARTERY. ON THE DAY OF THE PROCEDURE, THE PATIENT WAS BROUGHT TO THE ELECTROPHYSIOLOGY LABORATORY. GENERAL ANESTHESIA WAS ADMINISTRATED BY A CARDIAC ANESTHESIOLOGIST WITH A RADIAL ARTERIAL LINE FOR CONTINUOUS BLOOD PRESSURE MONITORING. AN IMPELLA CP WAS PLACED VIA THE LEFT FEMORAL ARTERY. THE DEVICE WAS POSITIONED ACROSS THE AORTIC VALVE ANNULUS, WITH APPROXIMATELY 3.5 CM FROM THE ANNULUS TO MID-INLET, AND AN ADDITIONAL 5.5CM FROM MID-INLET TO TIP OF THE PIGTAIL CATHETER.9 TRANSSEPTAL PUNCTURE WAS PERFORMED AND THE LV ENDOCARDIUM WAS MAPPED USING THE OPTRELL GRID CATHETER AND ELECTROANATOMIC MAPPING SYSTEM (CARTO 3, VERSION 7).. 10 GIVEN THE PATIENT¿S TENUOUS CLINICAL STATUS, A SUBSTRATE-BASED ABLATION APPROACH USING ISOCHRONAL LATEST ACTIVATION MAPPING WAS PLANNED. WHILE MAPPING THE LV ENDOCARDIUM, THE OPTRELL CATHETER BECAME DIFFICULT TO MANIPULATE AND WAS NOTED TO HAVE BEEN ENTANGLED IN THE IMPELLA CP PIGTAIL (FIGURE 2A/2B). AFTER SEVERAL ATTEMPTS AT CAREFUL MANIPULATION OF THE OPTRELL CATHETER WHILE HOLDING THE IMPELLA FIXED, THE OPTRELL CATHETER WAS FREED FROM THE PIGTAIL AND REMOVED FROM THE BODY WITHOUT COMPLICATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: OPTRELL CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: STEERABLE SHEATH IMPELLA DEVICE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNKNOWN OPTRELL MAPPING CATHETER QTY 1 DEVICE ENTRAPMENT WITHOUT EXCESSIVE MANIPULATION - NO PATIENT CONSEQUENCE AND NO PATIENT SIGNS, SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120385 OPTRELL CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CARTO 3.| STEERABLE SHEATH IMPELLA DEVICE.