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

Model Number	72404437
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced pain in the right scrotum and edema.Additionally, the patient experienced loss of penile length during erection.The events of pain and edema have been resolved.No additional information was provided.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The device history record (dhr) review was unable to be performed as the lot number was not provided, 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.The reported patient symptoms are known risk associated with this device type and indicated as such in the instructions for use.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced pain in the right scrotum and edema.Additionally, the patient experienced loss of penile length during erection.The events of pain and edema have been resolved.No additional information was provided.
Additional Manufacturer Narrative
Model number/catalog number 72404155.Serial number n/a.Batch/lot number n/a.Model/catalog description reservoir 65 ml pc/iz.Unique identifier (udi) # (b)(4).Detailed product information was not provided to bsc.Based on the nature of the information provided to bsc, it is not possible to perform a good faith effort to obtain additional information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.There was no report of a device performance allegation.The device history record (dhr) review was unable to be performed as the lot number was not provided, 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.The reported patient symptoms of edema, pain, and patient problem/ medical problem are known risks associated with this device type and indicated as such in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) experienced pain in the right scrotum and edema.Additionally, the patient experienced loss of penile length during erection.The events of pain and edema have been resolved.No additional information was provided.

• 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: 23851984
• Report Number: 2124215-2025-92084
• Device Sequence Number: 15942255
• Product Code: JCW
• UDI-Device Identifier: 00191506021382
• UDI-Public: (01)00191506021382
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404437
• Device Catalogue Number: 72404437
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 02/12/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/09/2026; 03/13/2026
• 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: 72404155; RESERVOIR: UPN: 72404155
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 90 KG