BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 9365757 · Received November 22, 2019

    Report

    Report Number
    2183959-2019-67636
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    November 6, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953002705
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A CYLINDER PUNCTURE WAS REPORTED. THE AMS700 IPP CYLINDERS WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. BOTH CYLINDERS HAD SEVERAL LEAKS THROUGHOUT THE BODY OF THE CYLINDER CONSISTENT WITH SHARP INSTRUMENT DAMAGE. PRODUCT ANALYSIS CONFIRMED THE ALLEGATION OF CYLINDER PUNCTURES. AN ALLEGATION OF A DIMPLED PUMP WAS REPORTED. THE AMS 700 MOMENTARY SQUEEZE (MS) PUMP WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED; NO LEAKS WERE FOUND. THE PUMP PERFORMED WITHIN SPECIFICATION; THE ALLEGATION OF A DIMPLED PUMP COULD NOT BE CONFIRMED. CORRECTION TO H2, H3, AND H6: UPDATED TO INCLUDE DEVICE ANALYSIS. PUMP MODEL- 7240431; LOT SN- (B)(6); MFG DATE- 09/19/2018; EXP DATE- 09/18/2023; GTIN- (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DUE TO A CYLINDER PUNCTURE AND DIMPLED PUMP THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS AND PUMP REMOVED AND REPLACED. THE COMPONENTS WERE EXPLANTED AND A NEW COMPONENTS CONSISTING OF A 18CMX9.5MM CYLINDERS AND PUMP WERE IMPLANTED. THE RESERVOIR REMAINS IMPLANTED. IT WAS FURTHER REPORTED THAT THE CYLINDER PUNCTURE WAS IDENTIFIED AFTER THE PHYSICIAN DID A TEST AFTER REMOVING THE OLD CYLINDER. THE PUNCTURE IS SAID TO HAVE OCCURRED DURING USE. THE LACK OF SALINE IN THE DEVICE CAUSE THE MALFUNCTION AND WHEN THE PHYSICIAN PRESSED THE PUMP BULB, THE PUMP STAYED FLAT. DUE TO THIS THE PATIENT WAS UNABLE TO INFLATE OF DEFLATE HIS DEVICE. THE PATIENT GOT WELL AFTER THIS SURGERY.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A CYLINDER PUNCTURE AND DIMPLED PUMP THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDERS AND PUMP REMOVED AND REPLACED. THE COMPONENTS WERE EXPLANTED AND A NEW COMPONENTS CONSISTING OF A 18CMX9.5MM CYLINDERS AND PUMP WERE IMPLANTED. THE RESERVOIR REMAINS IMPLANTED. IT WAS FURTHER REPORTED THAT THE CYLINDER PUNCTURE WAS IDENTIFIED AFTER THE PHYSICIAN DID A TEST AFTER REMOVING THE OLD CYLINDER. THE PUNCTURE IS SAID TO HAVE OCCURRED DURING USE. THE LACK OF SALINE IN THE DEVICE CAUSE THE MALFUNCTION AND WHEN THE PHYSICIAN PRESSED THE PUMP BULB, THE PUMP STAYED FLAT. DUE TO THIS THE PATIENT WAS UNABLE TO INFLATE OF DEFLATE HIS DEVICE. THE PATIENT GOT WELL AFTER THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1157414 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404013 0144710005 00878953002705

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R