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

Model Number	72404257
Medical Device Problem Codes	Collapse (1099); 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	01/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Correction to filed h3: device eval by manufacturer? correction to fields h6: evaluation method code, evaluation results code, evaluation conclusion codes.Correction to fields h11: additional mfr narrative.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited inflation issues, achieving only approximately 80% inflation.Additionally, after 8-10 pumps, the pump reportedly remained flat.During a subsequent surgical procedure, fluid loss was identified when the reservoir was emptied and only approximately 30 cc could be recovered.Further inspection determined both the source and the location of the fluid loss, identifying a hole in both cylinders at the junction where the tubing connects to the cylinders.The ipp was replaced, and no patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (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.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited inflation issues, achieving only approximately 80% inflation.Additionally, after 8-10 pumps, the pump reportedly remained flat.During a subsequent surgical procedure, fluid loss was identified when the reservoir was emptied and only approximately 30 cc could be recovered.Further inspection determined both the source and the location of the fluid loss, identifying a hole in both cylinders at the junction where the tubing connects to the cylinders.The ipp was replaced, and no patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1100232970.Model/catalog description: reservoir 65 ml pc/iz.Unique identifier (udi) #: (b)(4).Device technical analysis: upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder underwent microscopic inspection and leak testing.Microscopic evaluation revealed a hole at the corner of a fold and a torn outer sleeve at the proximal end.In addition, wear was observed at the folds in the proximal, middle, and distal sections of the cylinder.Leak testing confirmed a leak at the corner of a fold in the proximal end.The second cylinder was also microscopically inspected and leak tested.Inspection showed a hole in the outer tube caused by kink resistant tubing (krt) wear at the proximal end.Similar to the first cylinder, wear at the folds was noted in the proximal, middle, and distal regions.Leak testing identified a leak resulting from krt wear at the proximal end.The pump underwent microscopic inspection, leak testing, and functional testing.Microscopic evaluation revealed that the krt was worn down to the filament.The pump passed the leak test; however, it did not pass functional test 3 of the activation assessment.The reservoir was microscopically inspected and leak tested.The spherical reservoir passed both evaluations with no damage or abnormalities observed.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 events of "mechanical malfunction (leaks, incomplete inflation/ deflation, kinking)", "device has a fluid leak", and "excess force or friction on silicone leads to stress, strains, holes or tears" 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 available information and analysis results, the fluid leaks identified in the cylinders, along with the pump not passing the functional test, could have caused or contributed to the reported clinical observation of cylinder fluid leak, cylinder hole/perforated, device inflation issue, pump collapsed/dimpled/flat.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) exhibited inflation issues, achieving only approximately 80% inflation.Additionally, after 8-10 pumps, the pump reportedly remained flat.During a subsequent surgical procedure, fluid loss was identified when the reservoir was emptied and only approximately 30 cc could be recovered.Further inspection determined both the source and the location of the fluid loss, identifying a hole in both cylinders at the junction where the tubing connects to the cylinders.The ipp was replaced, and no patient complications were reported.

• 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: 24313007
• Report Number: 2124215-2026-07644
• Device Sequence Number: 11980621
• Product Code: JCW
• UDI-Device Identifier: 00878953003658
• UDI-Public: (01)00878953003658(17)250228(10)1100266889
• 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: 2023
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 03/30/2026

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 Expiration Date: 02/28/2025
• Device Model Number: 72404257
• Device Catalogue Number: 72404257
• Device Lot Number: 1100266889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 03/03/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/11/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: RESERVOIR: UPN: 72404155 / LOT: 1100232970; RESERVOIR: UPN: 72404155 / LOT: 1100232970
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male