BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    MDR report key: 20969578 · Received December 18, 2024

    Report

    Report Number
    3015053858-2024-00134
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 18, 2025
    Manufacturer
    SHOCKWAVE MEDICAL, INC.
    Product Code
    PPN
    PMA / PMN Number
    K203365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SHOCKWAVE MEDICAL CONFIRMED THAT THE PROCEDURE SUCCESSFULLY TREATED THE LEG. THE SHOCKWAVE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, FOLLOWED BY A PLANNED BELOW-KNEE AMPUTATION. THE PATIENT'S OUTCOME MET EXPECTATIONS, WITH EXCELLENT SHOCKWAVE RESULTS. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO SHOCKWAVE MEDICAL, INC. MULTIPLE ATTEMPTS WERE MADE TO COLLECT THE DEVICE. A PHOTO WAS PROVIDED, AND VISUAL EXAMINATION OF THE PHOTO CONFIRMED THE REPORTED ISSUE. HOWEVER, A PHYSICAL EXAMINATION WAS NOT ABLE TO BE PERFORMED THEREFORE THE CAUSE OF THE DEVICE DETACHMENT COULD NOT BE DETERMINED. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RECEIVED AT SHOCKWAVE MEDICAL, INC. THEREFORE, A PHYSICAL EXAMINATION HAS NOT BEEN PERFORMED. EVALUATION OF THE SUBJECT DEVICE IS ANTICIPATED BUT HAS NOT YET BEGUN. AFTER THE DEVICE IS RECEIVED AND INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SHOCKWAVE MEDICAL HAS CONTROLS IN PLACE TO ENSURE DEVICES ARE BUILT TO APPROVED PROCEDURES AND MEET LOT RELEASE ACCEPTANCE CRITERIA PRIOR TO BEING DISTRIBUTED. A REVIEW OF THE MANUFACTURING AND TEST DOCUMENTATION FOR SUBJECT LOT DOES NOT REVEAL ANY ISSUES WITH THE MANUFACTURING OF THE DEVICE. THE DEVICE PASSED ALL OF SHOCKWAVE MEDICAL, INC. ACCEPTANCE CRITERIA PRIOR TO SHIPPING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED TO SHOCKWAVE MEDICAL CONFIRMED THAT THE PROCEDURE SUCCESSFULLY TREATED THE LEG. THE SHOCKWAVE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, FOLLOWED BY A PLANNED BELOW-KNEE AMPUTATION. THE PATIENT'S OUTCOME MET EXPECTATIONS, WITH EXCELLENT SHOCKWAVE RESULTS.

    Description of Event or Problem · 0

    A SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER WAS USED TO TREAT A LESION IN LEG. IT WAS REPORTED THAT THE BALLOON CATHETER EXPERIENCED A LOSS OF PRESSURE AND SEPARATION OF THE BALLOON FROM THE SHAFT DURING USE. THE DETACHED BALLOON REMAINED WITHIN THE VESSEL. A COPIOUS SNARE PROCEDURE WAS PERFORMED TO RETRIEVE THE BALLOON, REQUIRING FORCE TO LOOSEN THE SHEATH AND BALLOON FROM THE VASCULAR PATCH. DUE TO THE COMPLEXITY OF THE CASE, IT WAS PERFORMED IN AN OPERATING THEATRE UNDER SPINAL. ADDITIONAL INFORMATION PROVIDED CONFIRMED THAT THE PROCEDURE AND TREATMENT WAS COMPLETED SUCCESSFULLY, AND THE PATIENT OUTCOME WAS AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949480 SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER PPN SHOCKWAVE MEDICAL, INC. M5PIVL5560 82296412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other