MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; prosthesis, penis, inflatable

Model Number	72404011
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tubing connection between the cylinder and the pump of this inflatable penile prosthesis (ipp) ruptured, resulting in fluid leakage near the pump connection.As a result, the device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that the tubing connection between the cylinder and the pump of this inflatable penile prosthesis (ipp) ruptured, resulting in fluid leakage near the pump connection.During revision surgery, a hole was observed near the pump and air was present within the device.A revision procedure was performed during which the device was explanted and replaced with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 77404310 serial number: n/a batch/lot number: 1100088810 model/catalog description: pump ms unique identifier (udi) #: (01)00878953003986(17)270217(10)1100088810 model number/catalog number: 720182-01 serial number: n/a batch/lot number: 1000527876 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (01)00878953005676(17)260214(10)1000527876.
Additional Manufacturer Narrative
Correction to field g1: mfr site country model number/catalog number: 77404310 serial number: n/a batch/lot number: 1100088810 model/catalog description: pump ms unique identifier (udi) #: (b)(4).Model number/catalog number: 720182-01 serial number: n/a batch/lot number: 1000527876 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4).

• 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: 50037979
• Report Number: 2124215-2026-40052
• Device Sequence Number: 13388626
• Product Code: JCW
• UDI-Device Identifier: 00878953002682
• UDI-Public: (01)00878953002682(17)250805(10)1000441935
• 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: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/05/2025
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1000441935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 07/19/2026; 09/09/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/18/2026; 09/25/2026
• Date Device Manufactured: 08/06/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 151 LB