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

Model Number	72404234-14
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Deformation (2976); Migration (4003); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Hematoma (1884); Discomfort (2330); Swelling/ Edema (4577)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with an inflatable penile prosthesis (ipp) came into a postoperative visit two weeks later with a hematoma, swelling, and the pump was displaced posteriorly.Two months post implant surgery the swelling had subsided.The patient returned to the clinic on (b)(6) 2026, and they could not inflate the cylinders by themselves, and they had discomfort in the perineum.A surgical procedure was performed.During the surgery, the physician noted the tubing was twisted and folded/retracted on itself on the right proximal top of the perineum, and there was a air and a leak in the system.No additional information was provided.
Additional Manufacturer Narrative
B3: date is unknown, so estimated date was entered.Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100887905 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 ; +1(508)652-1217
• MDR Report Key: 50936905
• Report Number: 2124215-2026-51755
• Device Sequence Number: 9589385
• Product Code: JCW
• UDI-Device Identifier: 00878953009803
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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): 09/29/2026

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: 72404234-14
• Device Catalogue Number: 72404234-14
• Device Lot Number: 1100723255
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 05/06/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male