BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 LGX

    MDR report key: 24111850 · Received January 19, 2026

    Report

    Report Number
    2124215-2026-03469
    Event Type
    Injury
    Date Received
    January 19, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953003955
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIELD G4: PREMARKET / 510(K) # EXCEEDS THE MINIMUM CHARACTER LIMIT ALLOWED; THE COMPLETE NUMBER IS N970012/P000053. MODEL NUMBER/CATALOG NUMBER 72404310 SERIAL NUMBER N/A BATCH/LOT NUMBER 1000332083 MODEL/CATALOG DESCRIPTION PUMP MS UNIQUE IDENTIFIER (UDI) # (B)(4). UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THE CYLINDERS AND PUMP OF THIS INFLATABLE PENILE PROSTHESIS (IPP) UNDERWENT A THOROUGH ANALYSIS. THE CYLINDERS WERE MICROSCOPICALLY INSPECTED AND TESTED FOR LEAKS. THE FIRST CYLINDER KINK RESISTANT TUBING (KRT) HAD A HOLE FROM SHARP INSTRUMENT DAMAGE. THE FIRST CYLINDER HAD WEAR AT FOLD IN THE PROXIMAL END AND DISTAL END OF THE CYLINDER. THE FIRST CYLINDER KINK RESISTANT TUBING (KRT) HAD A LEAK FROM SHARP INSTRUMENT DAMAGE. THE SECOND CYLINDER HAD A HOLE IN THE PROXIMAL END OF THE CYLINDER FROM SHARP INSTRUMENT. THE SECOND CYLINDER HAD WEAR AT FOLD IN THE PROXIMAL END AND DISTAL END OF THE CYLINDER. THE SECOND CYLINDER HAD A LEAK FROM SHARP INSTRUMENT IN THE PROXIMAL END OF THE CYLINDER. THE MS PUMP WAS MICROSCOPICALLY INSPECTED, LEAK AND FUNCTIONALLY TESTED. THE PUMP PASSED THE VISUAL INSPECTION. NO DAMAGE OR ABNORMALITIES WERE FOUND. NO LEAKS WERE FOUND IN THE PUMP. THE PUMP DID NOT PASS THE ACTIVATION TESTS 2 AND 3. BASED ON THE INVESTIGATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED ALLEGATION OF MECHANICAL ISSUE AND HOLE/PERFORATED ARE UNABLE TO BE CONFIRMED AS THE SHARP INSTRUMENT DAMAGE FOUND IN THE CYLINDERS IS CONSIDERED A SECONDARY FAILURE. HOWEVER, THE PUMP NOT PASSING THE FUNCTIONAL TEST COULD AFFECT THE PRODUCT PERFORMANCE. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF MECHANICAL MALFUNCTION (LEAKS, INCOMPLETE INFLATION/ DEFLATION, KINKING) AND DEVICE HAS A FLUID LEAK WERE DEFINED IN THE PRODUCT RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE WAS ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    FIELD G4: PREMARKET / 510(K) # EXCEEDS THE MINIMUM CHARACTER LIMIT ALLOWED; THE COMPLETE NUMBER IS N970012/P000053. CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE CYLINDER CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF THE CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE CYLINDER CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF THE CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. THE CYLINDERS AND PUMP WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297716 AMS 700 LGX PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 72404293 889210004 00878953003955

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R PUMP: UPN: 72404310 / LOT: 1000332083.