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

Model Number	72404433
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
Model number/catalog number: 72404156, serial number: n/a, batch/lot number: 1100709193, model/catalog description: reservoir 100 ml pc/iz, unique identifier (udi) #: (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) attended post-operative follow-up visits at three and six weeks, during which the device would not inflate.The physician stated that the product was defective.The patient further reported obtaining a second opinion from another physician, who also stated that the pump was defective and needed to be replaced.A surgical procedure was performed to remove the ipp and replace it with a non-boston scientific product.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: 25385238
• Report Number: 2124215-2026-29847
• Device Sequence Number: 18310281
• Product Code: JCW
• UDI-Device Identifier: 00191506021344
• UDI-Public: (01)00191506021344(17)270522(10)1100733953
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 72404433
• Device Catalogue Number: 72404433
• Device Lot Number: 1100733953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 05/22/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male