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

Model Number	72404438
Medical Device Problem Codes	Inflation Problem (1310); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was difficult to inflate to ideal rigidity after full implantation.Intraoperative testing with the pump external showed normal inflation.Once connected to the reservoir and fully internal, the implant required approximately 50 pumps to reach optimal rigidity and a small amount of air was observed in the device.The pressure relief valve was ruled out.The device remains implanted.Further discussion with the physician is planned to explore whether a larger dilation could help improve inflation.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Correction to field b2: outcomes attrib to adv event.Correction to field h1: type of reportable event.
Event or Problem Description
It was reported that, during implant procedure, this inflatable penile prosthesis (ipp) was difficult to inflate to ideal rigidity after full implantation.Intraoperative testing with the pump external showed normal inflation.Once connected to the reservoir and fully internal, the implant required approximately 50 pumps to reach optimal rigidity and a small amount of air was observed in the device.The pressure relief valve was ruled out.The device remains implanted.Further discussion with the physician is planned to explore whether a larger dilation could help improve inflation.There were no patient complications reported.
Additional Manufacturer Narrative
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.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 the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that, during implant procedure, this inflatable penile prosthesis (ipp) was difficult to inflate to ideal rigidity after full implantation.Intraoperative testing with the pump external showed normal inflation.Once connected to the reservoir and fully internal, the implant required approximately 50 pumps to reach optimal rigidity and a small amount of air was observed in the device.The pressure relief valve was ruled out.The device remains implanted.Further discussion with the physician is planned to explore whether a larger dilation could help improve inflation.There were no patient complications reported.
Additional Manufacturer Narrative
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.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 the cause that contributed to the reported event cannot be established.Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.
Event or Problem Description
It was reported that, during implant procedure, this inflatable penile prosthesis (ipp) was difficult to inflate to ideal rigidity after full implantation.Intraoperative testing with the pump external showed normal inflation.Once connected to the reservoir and fully internal, the implant required approximately 50 pumps to reach optimal rigidity and a small amount of air was observed in the device.The pressure relief valve was ruled out.The device remains implanted.Further discussion with the physician is planned to explore whether a larger dilation could help improve inflation.There were no patient complications reported.

• 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: 22583441
• Report Number: 2124215-2025-49042
• Device Sequence Number: 9340764
• Product Code: JCW
• UDI-Device Identifier: 00191506021399
• UDI-Public: (01)00191506021399(17)261126(10)1100636851
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/23/2026

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: 72404438
• Device Catalogue Number: 72404438
• Device Lot Number: 1100636851
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 10/15/2025; 01/20/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 07/23/2025; 11/07/2025; 01/23/2026
• Date Device Manufactured: 11/26/2024
• 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-0143-2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male