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

Model Number	72404232-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Purulent Discharge (1812); Unspecified Infection (1930); Swelling/ Edema (4577)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with an inflatable penile prosthesis (ipp) experienced swelling at the scrotal and infrapubic incision sites.The patient was initially treated with antibiotics.Subsequently, a small opening developed at the scrotal incision site, accompanied by noticeable discharge.The opening was reported to have enlarged compared to the previous evaluation.As a result, a surgical procedure was performed to explant the ipp and replace it with a tactra device.No device issues were identified.The patient is expected to be reevaluated for reimplantation of an ipp once the infection has completely resolved.The patient was also sent home with antibiotics.No additional patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100834145.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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50317577
• Report Number: 2124215-2026-44555
• Device Sequence Number: 9882747
• Product Code: JCW
• UDI-Device Identifier: 00878953009780
• UDI-Public: (01)00878953009780(17)271221(10)1100857977
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 08/19/2026

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: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1100857977
• 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: 08/19/2026
• Date Device Manufactured: 12/21/2025
• 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: 62 YR
• Patient Sex: Unknown