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

Model Number	72404236
Medical Device Problem Codes	Degraded (1153); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
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.Cylinder bulge is acknowledged within the dfu and is not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of the allegation 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 an aneurysm of the device.A revision surgery was performed, during which the physician explanted and replaced the prosthesis.No patient complications were reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with an aneurysm of the device.A revision surgery was performed, during which the physician explanted and replaced the prosthesis.No patient complications were reported.
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 evaluation.First cylinder was observed to have a hole consistent with sharp instrument damage at the proximal end of the cylinder and passed the leakage test.Second cylinder passed visual inspection with no damage or abnormalities observed and passed the leakage test.The ms pump passed visual inspection with no damage or abnormalities observed and passed the leakage test; however, the ms pump did not pass activation tests 2 and 3.The flat reservoir was observed to have a hole consistent with sharp instrument damage and exhibited a fluid leak attributed to sharp instrument damage.A review of the device history record (dhr) confirmed that the device met all material, assembly, and performance specifications.A review of the instructions for use (ifu) was completed and did not identify evidence of device misuse, off label use, or failure to follow instructions.Based on the available information and analysis results, the sharp instrument damage identified on the device was considered a secondary failure; therefore, the allegation of bulge could not be confirmed.Product analysis confirmed that the ms pump failed activation tests 2 and 3.A conclusion code of unable to exclude device problem 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: 23873075
• Report Number: 2124215-2025-88474
• Device Sequence Number: 17252806
• Product Code: JCW
• UDI-Device Identifier: 00878953003498
• UDI-Public: (01)00878953003498(17)250831(10)1100353538
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 02/27/2026

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: 08/31/2025
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1100353538
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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 1100583182, UPN 72018501; RESERVOIR LOT 1100583182, UPN 72018501
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male