MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404237
Medical Device Problem Codes	Collapse (1099); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning pump.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) number and other product specific information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir 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.Mechanical malfunction and incomplete inflation are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of allegations cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning pump that remained pressed.The device was explanted and replaced.There were no patient complications.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning pump that remained pressed.The device was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Under microscopic observation, the deflation ball and spring were found to be misaligned in the ms pump.The ms pump passed the leak test, and both cylinders passed visual inspection with no damage or abnormalities noted.Both cylinders also passed the leakage test.The ms pump failed the inflation test 1, deflation tests 1 and 2, and activation tests 2 and 3, and was unable to perform the valve active and de active state test, therefore functional testing was aborted.Based on the information available and analysis results, the allegation of mechanical issue and collapsed/dimpled/flat was most likely associated with the misaligned deflation ball/spring and the ms pump failing inflation test 1, deflation tests 1 and 2, activation tests 2 and 3, and being unable to perform the valve active and de active state test.A conclusion code of cause traced to component failure was assigned to this investigation.

• Brand Name: AMS 700 CX MS PUMP
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23086136
• Report Number: 2124215-2025-64860
• Device Sequence Number: 16073344
• Product Code: JCW
• UDI-Device Identifier: 00878953003504
• UDI-Public: (01)00878953003504(17)260703(10)1100541730
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/03/2026
• Device Model Number: 72404237
• Device Catalogue Number: 72404237
• Device Lot Number: 1100541730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 01/20/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/12/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR LOT 1100602731, UPN 72018501; RESERVOIR LOT 1100602731, UPN 72018501
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male