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

Model Number	72404429
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).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.Inflation issue, difficult to inflate and mechanical issue are acknowledged within the dfu and are not related to off-label use or failure to follow instructions.Additionally, it is concluded that the cause of the allegation cannot be established without product return.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
A patient with an inflatable penile prosthesis (ipp) reported difficulty inflating the pump.The clinic also noted that they were unable to get the device to function properly.A revision surgery was performed, during which the physician replaced the tenacio pump with an ms pump.There were no patient complications.

• Brand Name: AMS 700? 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: 24327777
• Report Number: 2124215-2026-08098
• Device Sequence Number: 10030474
• Product Code: JCW
• UDI-Device Identifier: 00191506021306
• UDI-Public: (01)00191506021306(17)260829(10)1100579596
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: 2026
• 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
• Report Date (Section B): 02/12/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2026
• Device Model Number: 72404429
• Device Catalogue Number: 72404429
• Device Lot Number: 1100579596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 08/29/2024
• 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-0138-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR LOT 1100670126, UPN 72018501
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male