BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZ SUPER STIFF

    MDR report key: 22154830 · Received June 5, 2025

    Report

    Report Number
    2124215-2025-36913
    Event Type
    Death
    Date Received
    June 5, 2025
    Date of Event
    August 1, 2022
    Report Date
    August 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B2: DATE OF DEATH AND BLOCK B3: DATE OF EVENT. DATES ARE APPROXIMATED. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK G2: LITERATURE SOURCE: ASHRAF, J., DEVALL, M., DOORN, V. D., KUMAR, R. (2022). ABDOMINAL COMPARTMENT SYNDROME AS A COMPLICATION OF PERCUTANEOUS NEPHROLITHOTOMY REQUIRING EXTRA-CORPOREAL LIFE SUPPORT, A CASE REPORT: PEDIATR MED 2022;5:32, HTTPS://DX.DOI.ORG/10.21037/PM-21-94. BLOCK H6: IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF LOW BLOOD PRESSURE/HYPOTENSION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE/BLOOD LOSS/BLEEDING. IMDRF PATIENT CODE E0514 CAPTURES THE REPORTABLE EVENT OF THROMBOSIS/THROMBUS. IMDRF PATIENT CODE E0731 CAPTURES THE REPORTABLE EVENT OF PLEURAL EFFUSION. IMDRF PATIENT CODE E130501 CAPTURES THE REPORTABLE EVENT OF RENAL FAILURE. IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST. IMDRF PATIENT CODE 2342 CAPTURES THE REPORTABLE EVENT OF MULTIPLE ORGAN DYSFUNCTION SYNDROME. IMDRF PATIENT CODE E060101 CAPTURES THE REPORTABLE EVENT OF ASYSTOLE. IMDRF PATIENT CODE E2402 CAPTURES THE REPORTABLE EVENT OF DISTENTION. IMDRF PATIENT CODE E2333 CAPTURES THE REPORTABLE EVENT OF PROLAPSE. IMDRF PATIENT CODE E0519 CAPTURES THE REPORTABLE EVENT OF REDUCED BLOOD FLOW. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F0801CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED.

    Additional Manufacturer Narrative · 0

    BLOCK B2: DATE OF DEATH AND BLOCK B3: DATE OF EVENT DATES ARE APPROXIMATED. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK G2: LITERATURE SOURCE: ASHRAF, J., DEVALL, M., DOORN, V. D., KUMAR, R. (2022). ABDOMINAL COMPARTMENT SYNDROME AS A COMPLICATION OF PERCUTANEOUS NEPHROLITHOTOMY REQUIRING EXTRA-CORPOREAL LIFE SUPPORT, A CASE REPORT: PEDIATR MED 2022;5:32, HTTPS://DX.DOI.ORG/10.21037/PM-21-94. BLOCK H6: IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF LOW BLOOD PRESSURE/HYPOTENSION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE/BLOOD LOSS/BLEEDING. IMDRF PATIENT CODE E0514 CAPTURES THE REPORTABLE EVENT OF THROMBOSIS/THROMBUS. IMDRF PATIENT CODE E0731 CAPTURES THE REPORTABLE EVENT OF PLEURAL EFFUSION. IMDRF PATIENT CODE E130501 CAPTURES THE REPORTABLE EVENT OF RENAL FAILURE. IMDRF PATIENT CODE E0602 CAPTURES THE REPORTABLE EVENT OF CARDIAC ARREST IMDRF PATIENT CODE 2342CAPTURES THE REPORTABLE EVENT OF MULTIPLE ORGAN DYSFUNCTION SYNDROME. IMDRF PATIENT CODE E060101 CAPTURES THE REPORTABLE EVENT OF ASYSTOLE. IMDRF PATIENT CODE E2402 CAPTURES THE REPORTABLE EVENT OF DISTENTION. IMDRF PATIENT CODE E2333 CAPTURES THE REPORTABLE EVENT OF PROLAPSE. IMDRF PATIENT CODE E0519 CAPTURES THE REPORTABLE EVENT OF REDUCED BLOOD FLOW. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F0801CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. BLOCK H11: ADDITIONAL INFORMATION UPDATED BLOCK B5: DESCRIBE EVENT OR PROBLEM. CORRECTION TO FIELD BLOCK H6: EVALUATION CONCLUSION CODES 1.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN PEDIATRIC MEDICINE THAT A STUDY WAS CONDUCTED TO REPORT A CASE OF A PEDIATRIC PATIENT WHO UNDERWENT PERCUTANEOUS NEPHROLITHOTOMY (PCNL). DURING THIS PROCEDURE, AN AMPLATZ SUPER STIFF GUIDEWIRE AND AMPLATZ ACCESS SHEATH WERE USED. IT WAS REPORTED THAT THE PROCEDURE WAS CHALLENGING SINCE THE BEGINNING DUE TO THE COMPLEX ANATOMY OF THE PATIENT, AND THE PROCEDURE TOOK LONGER THAN EXPECTED, AS IT LASTED ABOUT 5 HOURS INSTEAD OF THE TYPICAL 30 MINUTES OF PROCEDURE. THE PATIENT DEVELOPED ABDOMINAL COMPARTMENT SYNDROME (ACS) WITHOUT ANY WARNING SIGN. UPON COMPLETION AND REMOVAL OF DRAPES, THE PATIENT WAS TURNED SUPINE, AND IT WAS FOUND THAT THERE WAS A DISTENDED ABDOMEN, RECTAL PROLAPSE AND THE LEGS WERE MOTTLED AND POORLY PERFUSED. AN URGENT ULTRASOUND WAS REQUIRED, AND IT WAS OBSERVED THAT THERE WAS LARGE VOLUME RETROPERITONEAL COLLECTION, WHICH WAS PUSHING THE BLADDER AND BOWELS ANTERIORLY. SEPTATED FLUID WAS ALSO SEEN AROUND THE KIDNEYS, AND MORISON'S PUCH. ADDITIONALLY, THERE WERE BILATERAL PLEURAL EFFUSIONS; THE PATIENT BECAME HYPOTENSIVE AND REQUIRED FLUID RESUSCITATION AND PHENYLEPHRINE BOLUSES. THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU) WHERE TREATMENT CONTINUED AND WHERE THERE WAS ONGOING BLOOD LOSS FROM THE ABDOMEN. FOLLOWING READMISSION TO PICU, IT WAS REVEALED CLOTS IN THE LEFT PARASPINAL REGION/RENAL BED, AND CONSISTENT BLEEDING, MAKING THE EXACT BLEEDING POINTS UNIDENTIFIABLE. THERE WAS A DEVELOPMENT OF SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS); THE PATIENT ALSO EXPERIENCED MULTIORGAN FAILURE AND ACUTE KIDNEY INJURY. ANTIBIOTIC THERAPY WAS ALSO GIVEN TO THE PATIENT. THE HYPOTENSION CONTINUED DESPITE TREATMENT, AND IT WAS ALSO REVEALED HYPERDYNAMIC LEFT VENTRICULAR FUNCTION WITH MILDLY IMPAIRED RIGHT VENTRICULAR FILLING AND FUNCTION. THERE WAS NO RELENTLESS PROGRESSION OF THE SHOCK DESPITE MAXIMAL MEDICAL THERAPY. THE PATIENT EXPERIENCED INCREASING PERIODS OF BRADYCARDIA AND INTERMITTENT ASYSTOLE WITH WORSENING HYPOTENSION. PRIOR RETURNING TO PICU, FIXED DILATED PUPILS WERE FOUND IN THE PATIENT, THE HAEMODYNAMIC FINDINGS AND NEUROLOGICAL DETERIORATION WERE CONVEYED TO THE FAMILY, AND THE PATIENT ULTIMATELY PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN PEDIATRIC MEDICINE THAT A STUDY WAS CONDUCTED TO REPORT A CASE OF A PEDIATRIC PATIENT WHO UNDERWENT PERCUTANEOUS NEPHROLITHOTOMY (PCNL). DURING THIS PROCEDURE, AN AMPLATZ SUPER STIFF GUIDEWIRE AND AMPLATZ ACCESS SHEATH WERE USED. IT WAS REPORTED THAT THE PROCEDURE WAS CHALLENGING SINCE THE BEGINNING DUE TO THE COMPLEX ANATOMY OF THE PATIENT, AND THE PROCEDURE TOOK LONGER THAN EXPECTED, AS IT LASTED ABOUT 5 HOURS INSTEAD OF THE TYPICAL 30 MINUTES OF PROCEDURE. THE PATIENT DEVELOPED ABDOMINAL COMPARTMENT SYNDROME (ACS) WITHOUT ANY WARNING SIGN. UPON COMPLETION AND REMOVAL OF DRAPES, THE PATIENT WAS TURNED SUPINE, AND IT WAS FOUND THAT THERE WAS A DISTENDED ABDOMEN, RECTAL PROLAPSE AND THE LEGS WERE MOTTLED AND POORLY PERFUSED. AN URGENT ULTRASOUND WAS REQUIRED, AND IT WAS OBSERVED THAT THERE WAS LARGE VOLUME RETROPERITONEAL COLLECTION, WHICH WAS PUSHING THE BLADDER AND BOWELS ANTERIORLY. SEPTATED FLUID WAS ALSO SEEN AROUND THE KIDNEYS, AND MOSRISON'S PUCH. ADDITIONALLY, THERE WERE BILATERAL PLEURAL EFFUSIONS; THE PATIENT BECAME HYPOTENSIVE AND REQUIRED FLUID RESUSCITATION AND PHENYLEPHRINE BOLUSES. THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU) WHERE TREATMENT CONTINUED AND WHERE THERE WAS ONGOING BLOOD LOSS FROM THE ABDOMEN. FOLLOWING READMISSION TO PICU, IT WAS REVEALED CLOTS IN THE LEFT PARASPINAL REGION/RENAL BED, AND CONSISTENCE BLEEDING, MAKING THE EXACT BLEEDING POINTS UNIDENTIFIABLE. THERE WAS A DEVELOPMENT OF SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS); THE PATIENT ALSO EXPERIENCED MULTIORGAN FAILURE AND ACUTE KIDNEY INJURY. ANTIBIOTIC THERAPY WAS ALSO GIVEN TO THE PATIENT. THE HYPOTENSION CONTINUED DESPITE TREATMENT, AND IT WAS ALSO REVEALED HYPERDYNAMIC LEFT VENTRICULAR FUNCTION WITH MILDLY IMPAIRED RIGHT VENTRICULAR FILLING AND FUNCTION. THERE WAS NO RELENTLESS PROGRESSION OF THE SHOCK DESPITE MAXIMAL MEDICAL THERAPY. THE PATIENT EXPERIENCED INCREASING PERIODS OF BRADYCARDIA AND INTERMITTENT ASYSTOLE WITH WORSENING HYPOTENSION. PRIOR RETURNING TO PICU, FIXED DILATED PUPILS WERE FOUND IN THE PATIENT, THE HAEMODYNAMIC FINDINGS AND NEUROLOGICAL DETERIORATION WERE CONVEYED TO THE FAMILY, AND THE PATIENT ULTIMATELY PASSED AWAY. THE PHYSICIAN ASSESSED THAT NEITHER THE SHEATH NOR THE WIRE CONTRIBUTED TO THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS ATTRIBUTED TO THE PATIENT'S UNDERLYING CLINICAL CONDITION AND THE DEVELOPMENT OF ABDOMINAL COMPARTMENT SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493250 AMPLATZ SUPER STIFF STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Death