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

Model Number	72404253-12
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 720185-01, serial number: n/a, batch/lot number: 1000283969, 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.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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not inflating properly.Upon inspection, the cylinders appeared to show signs of material wear and structural compromise.Also, the device had fluid loss.As a result, the device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not inflating properly.Upon inspection, the cylinders appeared to show signs of material wear and structural compromise.Also, the device had fluid loss.As a result, the device was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinder 1 has a visual inspection where it was found detached outer sleeve and broken fabric threads from wear in the proximal end of the cylinder.The krt sleeve was worn through and krt was worn to filament.It also had a leakage test where it was found a bulge in the proximal end of the cylinder when inflated with syringe.The cylinder 2 had a visual test where the outer sleeve was detached from krt wear.The krt sleeve was worn through and krt was worn to filament.Cylinder 2 had wear at fold in the middle of the cylinder.It also had a leakage test where it was found a bulge in the proximal end and distal end of the cylinder when inflated with syringe.The reservoir was found to have a wear at a fold in reservoir shell under the visual inspection.The reservoir passed the leakage test.The pump went under microscope observation, contamination (bodily fluid) was found within the ms pump.The ms pump krt had a hole from fatigue.The ms pump krt were worn to the filament.It also was found that the ms pump krt had a leak from fatigue as the leakage test was done.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 mechanical malfunction (leaks, incomplete inflation/ deflation, kinking), device has a fluid leak, and device cylinder aneurysm/bulge were 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 and analysis results, the fluid loss and hole identified in the inflatable penile prosthesis (ipp) could have caused or contributed to the reported clinical observation.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, it can be concluded that the ms pump krt fluid leak was the most probable cause of the complaint/event.Model number/catalog number: 720185-01.Serial number: n/a.Batch/lot number: 1000283969.Model/catalog description: reservoir.Unique identifier (udi) # (b)(4).

• Brand Name: AMS 700 LGX 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: 25474158
• Report Number: 2124215-2026-31259
• Device Sequence Number: 21439147
• Product Code: JCW
• UDI-Device Identifier: 00878953009827
• UDI-Public: (01)00878953009827(17)200618(10)1000122275
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2026

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: 06/18/2020
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1000122275
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2026
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 06/12/2026; 08/03/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/09/2026; 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2018
• 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: 60 YR
• Patient Sex: Male