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

Model Number	72404437
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) underwent an unrelated abdominal surgery, during which the reservoir was emergently removed.Following the removal, the patient was unable to inflate the device.A hole and the presence of air within the device were noted as a consequence of the reservoir removal.As a result, all components of the prosthesis were explanted and replaced.No patient complications were 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.Based on the information available the cause that contributed to the reported event cannot be established.D4.Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with an inflatable penile prosthesis (ipp) underwent an unrelated abdominal surgery, during which the reservoir was emergently removed.Following the removal, the patient was unable to inflate the device.A hole and the presence of air within the device were noted as a consequence of the reservoir removal.As a result, all components of the prosthesis were explanted and replaced.No patient complications were 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.Based on the information available the cause that contributed to the reported event cannot be established.D4.Concomitant product udi for reservoir is (b)(4).Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.

• 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: 23376348
• Report Number: 2124215-2025-75839
• Device Sequence Number: 13034223
• Product Code: JCW
• UDI-Device Identifier: 00191506021382
• UDI-Public: (01)00191506021382(17)260510(10)1100509559
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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
• 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 Expiration Date: 05/10/2026
• Device Model Number: 72404437
• Device Catalogue Number: 72404437
• Device Lot Number: 1100509559
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/23/2026
• Date Device Manufactured: 05/10/2024
• 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-0142-2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male