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

Model Number	72404274
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); 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	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis ipp presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the right cylinder had a hole.The cylinder was explanted and replaced.There were no patient complications.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the right cylinder had a hole.The cylinder was explanted and replaced.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned component underwent a comprehensive evaluation.Microscope inspection revealed that the cylinder had a hole at corner of a fold in the middle of the cylinder and had wear at fold in the proximal end, middle, and distal end of the cylinder, not passing the microscope inspection.Leakage testing was performed, and cylinder was found to have a leak at corner of a fold in the middle of the cylinder also, not passing the test.Based on the information available and analysis results, the reason for the mechanical issue and the hole/perforation was most likely determined to be the leak at the corner of a fold in the cylinder from the test performed.Therefore, it can be concluded that the cylinder leak was the most probable cause of the complaint; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for pump is (b)(4).Udi field (d4) concomitant product udi for reservoir is (b)(4).Upon receipt at the quality assurance laboratory, the returned component underwent a comprehensive evaluation.Microscope inspection revealed that the cylinder had a hole at corner of a fold in the middle of the cylinder and had wear at fold in the proximal end, middle, and distal end of the cylinder, not passing the microscope inspection.Leakage testing was performed, and cylinder was found to have a leak at corner of a fold in the middle of the cylinder also, not passing the test.Based on the information available and analysis results, the reason for the mechanical issue and the hole/perforation was most likely determined to be the leak at the corner of a fold in the cylinder from the test performed.Therefore, it can be concluded that the cylinder leak was the most probable cause of the complaint; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the right cylinder had a hole.The cylinder was explanted and replaced.There were no patient complications.

• 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: 22508414
• Report Number: 2124215-2025-46676
• Device Sequence Number: 9303910
• Product Code: JCW
• UDI-Device Identifier: 00878953003818
• UDI-Public: (01)00878953003818(17)220227(10)165098004
• 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: 2021
• 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,Followup
• Report Date (Section B): 02/12/2026

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 Expiration Date: 02/27/2022
• Device Model Number: 72404274
• Device Catalogue Number: 72404274
• Device Lot Number: 0165098004
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 02/02/2026
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 10/10/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• 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: PUMP LOT 1000586406, UPN 72404310.; PUMP LOT 1000586406, UPN 72404310.; PUMP LOT 1000586406, UPN 72404310.; RESERVOIR LOT 1000263122, UPN 72018201.; RESERVOIR LOT 1000263122, UPN 72018201.; RESERVOIR LOT 1000263122, UPN 72018201.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male