MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX MS PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404257
Medical Device Problem Codes	Deflation Problem (1149); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during device preparation prior to implantation, the inflatable penile prosthesis (ipp) presented a mechanical problem.The cylinders inflated properly but failed to deflate when the deflation button was pressed.Manual attempts to deflate the cylinders were unsuccessful.An alternate device was used.There were no patient complications reported.
Event or Problem Description
It was reported that during device preparation prior to implantation, the inflatable penile prosthesis (ipp) presented a mechanical problem.The cylinders inflated properly but failed to deflate when the deflation button was pressed.Manual attempts to deflate the cylinders were unsuccessful.An alternate device was used.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this device underwent a thorough analysis.The cylinders and pump were microscopically examined, and leak tested; the pump was also functionally tested.Under microscope observation of the pump, the deflation ball was found to be misaligned and seated too far forward; the pump passed leak test but it did not pass deflation testing.Both cylinders passed visual inspection and leakage test.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) and device operates differently than expected 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 and analysis results, the pump deflation ball misalignment and the deflation problems found during functional testing could have caused or contributed to the reported clinical observation reported cylinder deflation problem and mechanical problem.

• 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: 24223408
• Report Number: 2124215-2026-05593
• Device Sequence Number: 8085597
• Product Code: JCW
• UDI-Device Identifier: 00878953003658
• UDI-Public: (01)00878953003658(17)271101(10)1100824416
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404257
• Device Catalogue Number: 72404257
• Device Lot Number: 1100824416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Male