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

Model Number	72404452
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was associated with patient dissatisfaction due to difficulty inflating the pump.The issue was primarily related to the patient's finger grip.The pump worked outside of the body, but inside the body it would not pump up properly.The physician suspected possible back pressure or kinked tubing.A surgical procedure was performed in which the pump was replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and leak tested.Microscope examination revealed that both cylinders had wear at fold in the middle of the cylinder.Both cylinders passed the leakage test.The tenacio pump was microscopically inspected, leak and functionally tested.The pump passed the visual inspection.No damage or abnormalities were found.The pump passed the leakage test and the functional testing.Based on the information available and analysis results, the reported allegations of pump difficult to inflate and kinked tubing are unable to be confirmed.This report is report is being submitted to correct the event description (b5) in section b, adverse event/ product problem.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was associated with patient dissatisfaction due to difficulty inflating the pump.The issue was primarily related to the patient's finger grip.The pump worked outside of the body, but inside the body it would not pump up properly.The physician suspected possible back pressure or kinked tubing.A surgical procedure was performed in which cylinders and pump were replaced.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was associated with patient dissatisfaction due to difficulty inflating the pump.The issue was primarily related to the patient's finger grip.The pump worked outside of the body, but inside the body it would not pump up properly.The physician suspected possible back pressure or kinked tubing.A surgical procedure was performed in which cylinders and pump were replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and leak tested.Microscope examination revealed that both cylinders had wear at fold in the middle of the cylinder.Both cylinders passed the leakage test.The tenacio pump was microscopically inspected, leak and functionally tested.The pump passed the visual inspection.No damage or abnormalities were found.The pump passed the leakage test and the functional testing.Based on the information available and analysis results, the reported allegations of pump difficult to inflate and kinked tubing are unable to be confirmed.Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.

• Brand Name: AMS 700 LGX? 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: 22308259
• Report Number: 2124215-2025-40535
• Device Sequence Number: 7924920
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)261018(10)1100614948
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2026

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 Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100614948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 01/20/2026
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/24/2025; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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-0143-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR ; RESERVOIR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male