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

Model Number	72404013
Medical Device Problem Codes	Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930)
Date of Event	01/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with fever and infection resulting in the discharge of pus.The patient was treated with antibiotics.The ipp was explanted and replaced.There is no additional information reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented with fever and infection resulting in the discharge of pus.The patient was treated with antibiotics.The ipp was explanted and replaced.There is no additional information reported.
Additional Manufacturer Narrative
Model number/catalog number: 720182-01.Serial number: n/a.Batch/lot number: 1100127593.Model/catalog description: reservoir.D4 unique identifier (udi): (b)(4).Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1100258974.Model/catalog description: pump ms.D4 unique identifier (b)(4).Updated concomitant components comment.Upon receipt at our quality assurance laboratory, this device underwent a thorough analysis.The cylinders, pump and reservoir were microscopically examined, and leak tested; the pump was also functionally tested.Testing of the first cylinder revealed wear at a fold in the middle of the cylinder, as well as holes in the middle and proximal end from a sharp instrument, which resulted in leakage in those areas.Testing of the second cylinder revealed wear at a fold in the middle of the cylinder; however, this component passed leakage testing.Regarding the momentary squeeze (ms) pump kink resistant tubing (krt), the clear krt had a hole from fatigue, while the black suture krt had a hole from sharp instrument damage.Both krts were worn down to the filament and presented fluid leaks from fatigue and sharp instrument damage.After trimming down the leaked krts, the ms pump passed leakage testing as performed, but it failed activation tests 2 and 3.Finally, regarding the reservoir, it was observed to have wear at a fold in the reservoir shell; the component passed leakage testing.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.A risk review was completed and confirmed that the event of fever, infection and purulent discharge was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• 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: 24193720
• Report Number: 2124215-2026-04846
• Device Sequence Number: 8065215
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)280321(10)1100277399
• 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: 2023
• Device Explanted Year: 2026
• 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): 03/16/2026

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: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 1100277399
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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: PUMP: UPN 72404310 / LOT 1100258974; PUMP: UPN 72404310 / LOT 1100258974; RESERVOIR: UPN 720182-01 / LOT 1100127593; RESERVOIR: UPN 720182-01 / LOT 1100127593
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 68 KG