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

Model Number	72404209
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310); Mechanical Problem (1384); Use of Device Problem (1670); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Scar Tissue (2060)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician noted that the pump was completely compressed and would not recoil.The physician suspected a significant accumulation of air within the system, and it was noted that there was a possibility the reservoir had not been properly prepped.Additionally, during the revision procedure, the device was not fully inspected due to patient complications and hemorrhage.Therefore, the device was explanted, and a tactra device was successfully implanted.There were no further patient complications.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician noted that the pump was completely compressed and would not recoil.The physician suspected a significant accumulation of air within the system, and it was noted that there was a possibility the reservoir had not been properly prepped.Additionally, during the revision procedure, the device was not fully inspected due to patient complications and hemorrhage.Therefore, the device was explanted, and a tactra device was successfully implanted.There were no further patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, it cannot be confirmed what the cause of the air in system/ component, mechanical issue, inflation issue, collapsed/dimpled/flat, and use of device issue was.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptom of hemorrhage is a known risk associated with this device type and indicated as such in the instructions for use.Without a returned product available for analysis and based on this investigation, a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established was selected.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician noted that the pump was completely compressed and would not recoil.The physician suspected a significant accumulation of air within the system, and it was noted that there was a possibility the reservoir had not been properly prepped.The physician noted the ipp was scarred significantly in the scrotal area requiring lysis of adhesions to gain access to the bilateral corpora cavernosum.The cylinders and pump were explanted intact.However, after removing the reservoir, uncontrolled bleeding occurred from the posterior to the rectus muscle.Vascular surgery was consulted to help control the bleeding.The iliac vessels deep and lateral to the area that was bleeding were ligated with a 4-0 prolene stitch.Once the bleeding was controlled and patient resuscitated, a tactra malleable implant was placed.The patient was then transferred to the intensive care unit where he received transfusion of red blood cells, fresh frozen plasma, albumin and iv fluids.After performing a ct, a hematoma was observed in the right rectus sheath.There were no further patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, it cannot be confirmed what the cause of the air in system/ component, mechanical issue, inflation issue, collapsed/dimpled/flat, and use of device issue was.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptom of hemorrhage is a known risk associated with this device type and indicated as such in the instructions for use.Without a returned product available for analysis and based on this investigation, a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established was selected.
Additional Manufacturer Narrative
Correction to field h6: device codes.Correction to field h6: impact codes.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, it cannot be confirmed what the cause of the air in system/ component, mechanical issue, collapsed/dimpled/flat, and use of device issue was.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptom of hemorrhage is a known risk associated with this device type and indicated as such in the instructions for use.Without a returned product available for analysis and based on this investigation, a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established was selected.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician noted that the pump was completely compressed and would not recoil.The physician suspected a significant accumulation of air within the system, and it was noted that there was a possibility the reservoir had not been properly prepped.The physician noted the ipp was scarred significantly in the scrotal area requiring lysis of adhesions to gain access to the bilateral corpora cavernosum.The cylinders and pump were explanted intact.However, after removing the reservoir, uncontrolled bleeding occurred from the posterior to the rectus muscle.Vascular surgery was consulted to help control the bleeding.The iliac vessels deep and lateral to the area that was bleeding were ligated with a 4.0 prolene stitch.Once the bleeding was controlled and patient resuscitated, a tactra malleable implant was placed.The patient was then transferred to the intensive care unit where he received transfusion of red blood cells, fresh frozen plasma, albumin and iv fluids.After performing a ct, a hematoma was observed in the right rectus sheath.There were no further patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, it cannot be confirmed what the cause of the air in system/ component, mechanical issue, collapsed/dimpled/flat, and use of device issue was.Based on the device history record (dhr), the device was confirmed to meet specifications prior to shipment therefore concluding manufacturing was not related to the reported event.The reported patient symptom of hemorrhage is a known risk associated with this device type and indicated as such in the instructions for use.Without a returned product available for analysis and based on this investigation, a clear probable cause for the event cannot be established; therefore, the conclusion code of cause not established was selected.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician noted that the pump was completely compressed and would not recoil.The physician suspected a significant accumulation of air within the system, and it was noted that there was a possibility the reservoir had not been properly prepped.The physician noted the ipp was scarred significantly in the scrotal area requiring lysis of adhesions to gain access to the bilateral corpora cavernosum.The cylinders and pump were explanted intact.However, after removing the reservoir, uncontrolled bleeding occurred from the posterior to the rectus muscle.Vascular surgery was consulted to help control the bleeding.The iliac vessels deep and lateral to the area that was bleeding were ligated with a 4.0 prolene stitch.Once the bleeding was controlled and patient resuscitated, a tactra malleable implant was placed.The patient was then transferred to the intensive care unit where he received transfusion of red blood cells, fresh frozen plasma, albumin and iv fluids.After performing a ct, a hematoma was observed in the right rectus sheath.There were no further patient complications.

• 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: 23751630
• Report Number: 2124215-2025-87085
• Device Sequence Number: 9321380
• Product Code: JCW
• UDI-Device Identifier: 00878953003351
• UDI-Public: (01)00878953003351(17)261212(10)1100642732
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/27/2026

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: 72404209
• Device Catalogue Number: 72404209
• Device Lot Number: 1100642732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 12/22/2025; 01/22/2026; 02/13/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/13/2026; 01/21/2026; 02/12/2026; 02/27/2026
• Date Device Manufactured: 12/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 115 KG