MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CX MS Pump; prosthesis, penis, inflatable

Model Number	72404238
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematuria (2558); Dysuria (2684); Swelling/ Edema (4577)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this inflatable penile prosthesis (ipp) returned following discharge due to painful urination, hematuria, and penoscrotal swelling.A cystoscopy was performed and a cylinder was observed in the distal urethra.A surgical procedure was performed during which further examination noted both the right and left cylinders had perforated the urethra.The device was removed, a betadine washout was performed, a foley catheter was placed and the patient was given antibiotics.No further patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: n/a, batch/lot number: 1100855423, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) #: (b)(4).

• Brand Name: AMS 700 CX MS Pump
• 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; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50361971
• Report Number: 2124215-2026-45074
• Device Sequence Number: 16118390
• Product Code: JCW
• UDI-Device Identifier: 00878953003511
• UDI-Public: (01)00878953003511(17)270711(10)1100759786
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1100759786
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 07/11/2025
• 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: 61 YR
• Patient Sex: Male