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

Model Number	72404281
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) could not be used normally as it could not be pressed, resulting in the inability of the penis to achieve an erection.A surgical procedure was performed to remove and replace the ipp.No patient complications were reported.
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) could not be used normally as it could not be pressed, resulting in the inability of the penis to achieve an erection.A surgical procedure was 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, the cylinders and pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically inspected and tested for leaks.Microscope examination revealed that both cylinders had a hole in the proximal end of the cylinder from sharp instrument.Both cylinders had wear at fold in the proximal end and middle of the cylinder.Both cylinders had a leak from sharp instrument in the proximal end of the cylinder.The pump was microscopically inspected, leak and functionally tested.Microscope examination revealed that the spring was found to be misaligned in the pump.No leaks were found in the pump.The pump passed the functional test.The reservoir was microscopically inspected and tested for leaks.The reservoir passed the visual inspection.No damage or abnormalities were found.No leaks were found in the reservoir.Based on the information available and analysis results, the sharp instrument damage is considered a secondary failure, so the allegation of inflation issue and mechanical issue are unable to 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, a conclusion code of cause not established 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: 23012199
• Report Number: 2124215-2025-63165
• Device Sequence Number: 9665191
• Product Code: JCW
• UDI-Device Identifier: 00878953003849
• UDI-Public: (01)00878953003849(17)300219(10)1100679048
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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 Model Number: 72404281
• Device Catalogue Number: 72404281
• Device Lot Number: 1100679048
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: 1100635515; RESERVOIR: UPN: 720182-01 / LOT: 1100635515
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 89 KG