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

Model Number	72404209
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	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not inflating, causing the device to stopped working.A surgical procedure was performed, during which a fluid loss and a hole was identified in the right cylinder.Therefore, the ipp was removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for cylinders is (b)(4).
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Concomitant product udi for cylinders is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The 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.Functional test revealed that the pump did not pass the activation test.Both cylinders were microscopically inspected and tested for leaks.The first cylinder had a hole in the distal tip of the cylinder from sharp instrument.The first cylinder had a hole in the middle of the cylinder from sharp instrument.The first cylinder had wear at fold in the proximal end and distal end of the cylinder.The first cylinder had a leak from sharp instrument damage in the distal tip of the cylinder.The first cylinder had a leak from sharp instrument in the middle of the cylinder.The second cylinder had wear at fold in the proximal end and distal end of the cylinder.The second cylinder had a hole in the middle of the cylinder from sharp instrument.The second cylinder had a leak from sharp instrument damage in the middle of the cylinder.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.Based on the information available and analysis results, the reason for the inflation issue was most likely determined to be the pump not passing the activation test.The instrument damage found on the device is considered a secondary failure, so the allegations of cylinder hole/perforation and fluid leak are unable to 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.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not inflating, causing the device to stopped working.A surgical procedure was performed, during which a fluid loss and a hole was identified in the right cylinder.Therefore, the ipp was removed and replaced.No patient complications were reported.

• Brand Name: 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: 22911444
• Report Number: 2124215-2025-60096
• Device Sequence Number: 15669317
• Product Code: JCW
• UDI-Device Identifier: 00878953003351
• UDI-Public: (01)00878953003351(17)260307(10)1100463477
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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: 03/07/2026
• Device Model Number: 72404209
• Device Catalogue Number: 72404209
• Device Lot Number: 1100463477
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: CYLINDERS: UPN: 72404174 / LOT: 1100547918.; CYLINDERS: UPN: 72404174 / LOT: 1100547918.; RESERVOIR: UPN: 72404155 / LOT: 1100366175.; RESERVOIR: UPN: 72404155 / LOT: 1100366175.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male