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

Model Number	72404012
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930); Perforation (2001)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) had a cylinder eroded into the urethra and was associated with an infection.A revision procedure was performed during which the device was explanted.Following the procedure, the patient developed infectious symptoms.No additional information regarding the procedure outcome or event resolution was reported.
Additional Manufacturer Narrative
Concomitant product implanted at the time of the event: model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1100299821.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72018201.Serial number: n/a.Batch/lot number: 1100287625.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: 50893025
• Report Number: 2124215-2026-51091
• Device Sequence Number: 17648932
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)280321(10)1100277392
• 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: 2021
• 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): 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 Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1100277392
• 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: 08/28/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/25/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 165 LB