MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700? CX TENACIO? PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404439
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250); Inflation Problem (1310); Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced difficulty inflating the inflatable penile prosthesis more than three quarters erect, resulting in insufficient rigidity for penetration.The patient noted dissatisfaction with their device and stated that they had not received formal pump training and contacted their physician.The patient was counseled on expectations, the difference between natural and prosthetic erections, and proper inflation techniques.Additional information was received indicating the physician suspected a fluid leak in the system for which additional evaluation would be performed and potentially a revision surgery.There were no patient complications or further information reported.
Event or Problem Description
It was reported that a patient experienced difficulty inflating the inflatable penile prosthesis ipp more than three quarters erect, resulting in insufficient rigidity for penetration.Also, the patient noted discomfort and difficulty with inflation and deflation with their device and stated that they had not received formal pump training and contacted their physician.The patient was counseled on expectations, the difference between natural and prosthetic erections, and proper inflation techniques.Additional information indicated that the physician suspected a fluid leak within the system and confirmed that the pump did not seat well in the scrotum.A replacement surgery was performed, during which the pump was replaced.There were no further patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).There was no device 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 deflation issue, inflation issue, pump difficulty to inflate, or fluid leak was.Additionally, the reported allegations of discomfort and migration are known risks associated with implant of this device as indicated in the instructions for use (ifu).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.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 has been chosen.
Event or Problem Description
It was reported that a patient experienced difficulty inflating the inflatable penile prosthesis (ipp) more than three quarters erect, resulting in insufficient rigidity for penetration.Also, the patient noted discomfort and difficulty with inflation and deflation with their device and stated that they had not received formal pump training and contacted their physician.The patient was counseled on expectations, the difference between natural and prosthetic erections, and proper inflation techniques.Additional information indicated that the physician suspected a fluid leak within the system and confirmed that the pump did not seat well in the scrotum.A replacement surgery was performed, during which the pump was replaced.There were no further patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).There was no device 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 deflation issue, inflation issue, pump difficulty to inflate, or fluid leak was.Additionally, the reported allegations of discomfort and migration are known risks associated with implant of this device as indicated in the instructions for use (ifu).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.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 has been chosen.Correction to h7 if remedial act init, type.Correction to h9 correction/removal reporting #.
Event or Problem Description
It was reported that a patient experienced difficulty inflating the inflatable penile prosthesis (ipp) more than three quarters erect, resulting in insufficient rigidity for penetration.Also, the patient noted discomfort and difficulty with inflation and deflation with their device and stated that they had not received formal pump training and contacted their physician.The patient was counseled on expectations, the difference between natural and prosthetic erections, and proper inflation techniques.Additional information indicated that the physician suspected a fluid leak within the system and confirmed that the pump did not seat well in the scrotum.A replacement surgery was performed, during which the pump was replaced.There were no further patient complications.

• Brand Name: AMS 700? CX TENACIO? 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: 21748679
• Report Number: 2124215-2025-20163
• Device Sequence Number: 13120957
• Product Code: JCW
• UDI-Device Identifier: 00191506021405
• UDI-Public: (01)00191506021405(17)260920(10)1100595686
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/20/2026

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: 09/20/2026
• Device Model Number: 72404439
• Device Catalogue Number: 72404439
• Device Lot Number: 1100595686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 10/13/2025; 01/20/2026
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/15/2025; 11/04/2025; 01/20/2026
• Date Device Manufactured: 09/20/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0142-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR UPN 72018501, LOT 1100559128.; RESERVOIR UPN 72018501, LOT 1100559128.; RESERVOIR UPN 72018501, LOT 1100559128.; RESERVOIR UPN 72018501, LOT 1100559128.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Unknown