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

Model Number	72404283
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504); Connection Problem (2900); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working as the pump remained collapsed when an attempt was made to inflate it.A physical and ultrasound-assisted evaluation was performed.During the ultrasound, it was determined that the cylinders were not fully expanding.The physician acoustically detected the presence of air in the device and determined that the reservoir was completely empty and collapsed, leading to the assumption that one of the cylinder's tubing or the tube connecting the pump to the reservoir had ruptured.Additionally, the suspected cause of the pump issue is a disconnection.As a result, replacement surgery has been performed to remove and replace the ipp.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not working as the pump remained collapsed when an attempt was made to inflate it.A physical and ultrasound-assisted evaluation was performed.During the ultrasound, it was determined that the cylinders were not fully expanding.The physician acoustically detected the presence of air in the device and determined that the reservoir was completely empty and collapsed, leading to the assumption that one of the cylinder's tubing or the tube connecting the pump to the reservoir had ruptured.Additionally, the suspected cause of the pump issue is a disconnection.As a result, replacement surgery has been performed to remove and replace the ipp.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The ms pump was visually inspected, leak and functionally tested.Visual inspection revealed that the pump had worn down to the filament.No leaks were found in the pump.The pump passed the functional test.The cylinders were visually inspected and tested for leaks.The first cylinder had wear at fold in the middle of the cylinder.The first cylinder had a hole from sharp instrument in the distal and proximal end of the cylinder.The first cylinder had a leak from the sharp instrument damage found.The second cylinder had wear at fold in the distal and proximal end of the cylinder.No leaks were found in the second cylinder.The reservoir was visually inspected and tested for leaks.The reservoir passed the visual inspection.No damage or abnormalities were found.No leaks were found in the cylinder.The window quick connect was visually inspected and tested for leaks.The window quick connect passed both visual inspection and leakage test.Based on the information available and analysis results, the sharp instrument damage to the first cylinder most likely occurred during the explant procedure and is considered a secondary failure, and the tubing was not returned for analysis.Therefore, the reported device performance allegations of disconnection, inflation issue, collapsed/dimpled/flat, and hole/perforate are unable to be confirmed.Additionally, the reported reservoir performance allegations of a mechanical issue and fluid leak could not be confirmed, as they were not substantiated during functional testing.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.Based on the information available, 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: 23848576
• Report Number: 2124215-2025-91330
• Device Sequence Number: 9543610
• Product Code: JCW
• UDI-Device Identifier: 00878953003863
• UDI-Public: (01)00878953003863(17)250318(10)1000414050
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• 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: 03/18/2025
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 1000414050
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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: UPN: 720182-01 / LOT: 1000510443; RESERVOIR: UPN: 720182-01 / LOT: 1000510443
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male