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

Model Number	72404232-10
Medical Device Problem Codes	Deflation Problem (1149); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Hemorrhage/Blood Loss/Bleeding (1888); Scar Tissue (2060)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced bleeding approximately three weeks after implantation of the inflatable penile prosthesis (ipp).The bleeding subsequently resulted in tissue scarring, causing the pump to become high riding and fixed within the surrounding scar tissue.As a result, the pump was unable to function properly, and the device could not be deflated.A surgical procedure was performed during which the pump was explanted, scar tissue was removed from the scrotum, and a new tenacio pump was implanted.The new pump was connected to the previously implanted cylinders, tested, and confirmed to be functioning properly.No additional patient complications were reported.
Additional Manufacturer Narrative
Concomitant products implanted at the time of the event: model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1100904921.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: 50553500
• Report Number: 2124215-2026-46727
• Device Sequence Number: 18737901
• Product Code: JCW
• UDI-Device Identifier: 00878953009780
• UDI-Public: (01)00878953009780(17)280303(10)1100915393
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/01/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1100915393
• 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: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 03/04/2026
• 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: 72 YR
• Patient Sex: Unknown