MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404012
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a hole was identified in the left cylinder.Both cylinders and the pump were explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for pump is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were visually and microscopically inspected and leakage tested.Microscope examination revealed that the first cylinder had a detached outer sleeve and broken fabric threads from fatigue in the proximal end of the cylinder, as well as a hole from wear in the proximal end.Leakage testing revealed that the first cylinder had a leak from fatigue in the proximal end of the cylinder.Microscope examination of the second cylinder revealed wear at a fold in the proximal end and middle of the cylinder; however, the second cylinder passed the leakage test.The pump was microscopically inspected and leak tested.Microscope examination revealed contamination (bodily fluid) within the pump.The pump passed the leakage test.Based on the available information and analysis results, the leak from fatigue identified in the first cylinder could have caused or contributed to the reported observation of a hole/perforation and mechanical issue.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 traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a hole was identified in the left cylinder.Both cylinders and the pump were explanted and replaced.There were no patient complications reported.

• Brand Name: AMS 700 CXR
• 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: 23347388
• Report Number: 2124215-2025-74097
• Device Sequence Number: 9451933
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)280610(10)1100314637
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/12/2026

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 Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1100314637
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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: LOT:1100311265 UPN:72404310. PUMP; LOT:1100311265 UPN:72404310. PUMP; LOT:174957018 UPN:72404161. RESERVOIR; LOT:174957018 UPN:72404161. RESERVOIR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male