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

Model Number	72404014
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) developed and infection, and the device exhibited fluid loss.A surgical procedure was performed to remove the ipp.No further patient complications were reported.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) developed an infection at the incision site, and the device exhibited fluid loss.A surgical procedure was performed to remove the ipp.The infection was treated with combined antibiotic therapy.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72018201, (b)(6) batch/lot number: 1100475343, model/catalog description: reservoir flat 100 ml, unique identifier (udi) #: (b)(4).Model number/catalog number: 72404310, batch/lot number: 1100703679, model/catalog description: pump ms, unique identifier (udi) #: (b)(4).
Additional Manufacturer Narrative
Correction to field b3: date of event model number/catalog number: 72018201 serial number: n/a batch/lot number: 1100475343 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4) model number/catalog number: 72404310 serial number: n/a batch/lot number: 1100703679 model/catalog description: pump ms 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: 50209688
• Report Number: 2124215-2026-42901
• Device Sequence Number: 15947818
• Product Code: JCW
• UDI-Device Identifier: 00878953002712
• UDI-Public: (01)00878953002712(17)301006(10)1100808512
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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 Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1100808512
• 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: 07/16/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 10/07/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male