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

Model Number	72404302
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) does not inflate when the patient presses the pump.A surgical procedure was performed to remove and replace the ipp.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.
Additional Manufacturer Narrative
Correction to field b3: date of event.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 this inflatable penile prosthesis (ipp) does not inflate when the patient presses the pump.A surgical procedure was performed to remove and replace the ipp.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) does not inflate when the patient presses the pump.A surgical procedure was performed to remove and replace the ipp.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem correction to field c2/d10: concomitant product/therapy model number/catalog number: 72018201 serial number: n/a batch/lot number: 1100197729 model/catalog description: reservoir flat 100 ml unique identifier (udi) #: (b)(4) upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.Both cylinders had a hole in the middle of the cylinder from sharp instrument.Both cylinders had a leak from sharp instrument in the middle of the cylinder.The ms pump was microscopically inspected, leak and functionally tested.The pump passed the visual inspection.No damage or abnormalities were found.No leaks were found in the pump.The pump did not pass the activation test 3.The reservoir was microscopically inspected and tested for leaks.The reservoir passed the visual inspection.No damage or abnormalities were found.No leaks were found in the reservoir.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) 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 sharp instrument damage found in the cylinders is considered a secondary failure, so the allegation of a pump inflation issue was unable to be confirmed.Additionally, the pump did not pass the activation test 3; however, the pump not passing this test alone would not result in the inability for the pump to inflate the cylinders.Therefore, a conclusion code of cause not established was assigned to this investigation.

• 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: 23934334
• Report Number: 2124215-2025-93947
• Device Sequence Number: 9610782
• Product Code: JCW
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

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 Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1100173042
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 06/05/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/22/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2022
• 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: 720182-01 / LOT: 1100197729; RESERVOIR: UPN: 720182-01 / LOT: 1100197729.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Male