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

Model Number	72404272
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation of a hole cannot be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) did not work properly.Two weeks later, the patient underwent surgery, and a hole was identified in the left cylinder.As a result, both cylinders and the pump were replaced during the procedure.The cause of the cylinder hole was not detailed by the hospital.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were microscopically examined and leak tested.Microscope inspection revealed that the first cylinder had broken fabric threads from wear in the middle and distal end, as well as wear at the fold in the middle region.The first cylinder passed the leakage test.The second cylinder showed broken fabric threads from wear in the proximal end and middle region, along with a pinhole leak consistent with sharp instrument damage at the proximal end.The standard inflate/deflate pump was also microscopically examined and leak tested.Inspection revealed that the kink resistant tubing (krt) was worn to the filament and the outer layer of the pump bulb was worn from friction against the pump strain relief krt junction.Additionally, scaling was observed on the outside surface of the pump.The pump passed the leakage test.Based on the available information, the reported cylinder perforation could not be confirmed as a primary event.However, multiple wear-related conditions were identified that could contribute to a mechanical issue, including the broken fabric threads in both cylinders and wear on the pump bulb surface.Therefore, a clear probable cause for the reported event could not be established, and a conclusion code of cause not established has been assigned.
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) did not work properly.Two weeks later, the patient underwent surgery, and a hole was identified in the left cylinder.As a result, both cylinders and the pump were replaced during the procedure.The cause of the cylinder hole was not detailed by the hospital.There were no patient complications reported.

• Brand Name: AMS 700 CX
• 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: 22501958
• Report Number: 2124215-2025-46040
• Device Sequence Number: 7013430
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)200921(10)104645001
• 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: 2016
• 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): 10/14/2025

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 Expiration Date: 09/21/2020
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 104645001
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male