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

Model Number	72404439
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis ipp experienced difficulty inflating the device, as the pump was too hard to compress.Both the patient and the physician noted that it required the use of both hands and extended time to inflate the ipp.The device was explanted.No patient complications were reported.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for reservoir is (b)(4).Correction to field h6: device codes.Upon receipt at the quality assurance laboratory, the returned components underwent a comprehensive evaluation.Microscope inspection revealed no damage or abnormalities were found, passing the test.Leakage testing was performed, and pump passed the test.Functional testing was not passed due to pump not passing inflation test 1 and 2.Based on the information available and analysis results, the mechanical issue and difficult to inflate condition was most likely determined to be the pump not passing inflation tests 1 and 2 from the functional test performed.A conclusion code of cause traced to component issue was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis ipp experienced difficulty inflating the device, as the pump was too hard to compress.Both the patient and the physician noted that it required the use of both hands and extended time to inflate the ipp.The device was explanted.No patient complications were 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: 22285476
• Report Number: 2124215-2025-40134
• Device Sequence Number: 8467745
• Product Code: JCW
• UDI-Device Identifier: 00191506021405
• UDI-Public: (01)00191506021405(17)261104(10)1100624256
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: 72404439
• Device Catalogue Number: 72404439
• Device Lot Number: 1100624256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR LOT 1100662829, UPN 72018501.; RESERVOIR LOT 1100662829, UPN 72018501.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male