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

Model Number	72404231
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384); Material Puncture/Hole (1504); Migration (4003); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Unspecified Tissue Injury (4559)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced testicular pain and was unable to inflate the device.A ct scan was performed, which showed that the reservoir appeared collapsed, with air present in the pump and cylinders, indicating a possible system leak.Additionally, asymmetry in the distal position of the cylinders was observed with sub centimetric calcifications in the soft tissues.A follow up ct scan performed a few months later demonstrated that the cylinders appeared broken, with persistent air presence and continued asymmetry in cylinder positioning.The device remains implanted, and an explant surgery is planned.No additional information was reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1100366081.Model/catalog description: reservoir.Unique identifier (udi) # (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of pain, tissue damage, air in system/ component, hole/ perforated, migration, fluid leak, and inflation issue, was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available the cause that contributed to the reported event cannot be established.Therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced testicular pain and was unable to inflate the device.A ct scan was performed, which showed that the reservoir appeared collapsed, with air present in the pump and cylinders, indicating a possible system leak.Additionally, asymmetry in the distal position of the cylinders was observed with sub centimetric calcifications in the soft tissues.A follow up ct scan performed a few months later demonstrated that the cylinders appeared broken, with persistent air presence and continued asymmetry in cylinder positioning.The device remains implanted, and an explant surgery is planned.No additional information was reported.

• 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: 24502254
• Report Number: 2124215-2026-11823
• Device Sequence Number: 10456541
• Product Code: JCW
• UDI-Device Identifier: 00878953003443
• UDI-Public: (01)00878953003443(17)250619(10)1100316831
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Expiration Date: 06/19/2025
• Device Model Number: 72404231
• Device Catalogue Number: 72404231
• Device Lot Number: 1100316831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 08/27/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/08/2026; 09/25/2026
• Date Device Manufactured: 06/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LOT:1100366081 UPN:72404155
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 43 YR
• Patient Sex: Male