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

Model Number	72404452
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event b3 approximated.D4 unique identifier (udi) for reservoir: (b)(4).
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented a mechanical problem, the physician reported that the pump felt squishy and was indicative of fluid loss.It was discovered that the pump had air bubbles and dark fluid.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event b3 approximated.D4 unique identifier (udi) for reservoir: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The components were visually and microscopically examined, and leak tested.Visual and microscopic examination of one cylinder had a hole in the distal end of the cylinder from sharp instrument that occurred during explant; this cylinder did not pass leak testing due to this hole.Regarding the other cylinder, it had worn at fold in the proximal end and distal end of the cylinder.This cylinder passed the leakage test.In relation to the pump, it was microscopically inspected, and contamination (bodily fluid) was found within the pump.Pump passed the leakage test.Lastly, the reservoir was noted to have wear at a fold in reservoir shell., and it passed the leak testing.Based on the information available and analysis results, a clear probable cause for the event cannot be established.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented a mechanical problem, the physician reported that the pump felt squishy and was indicative of fluid loss.It was discovered that the pump had air bubbles and dark fluid.The ipp was explanted and replaced.There were no patient complications reported.

• 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: 22577289
• Report Number: 2124215-2025-47756
• Device Sequence Number: 15864769
• Product Code: JCW
• UDI-Device Identifier: 00191506021436
• UDI-Public: (01)00191506021436(17)260612(10)1100529953
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 08/27/2025

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 Expiration Date: 06/12/2026
• Device Model Number: 72404452
• Device Catalogue Number: 72404452
• Device Lot Number: 1100529953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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: UPN 720185-01 / LOT 1100647816.; RESERVOIR: UPN 720185-01 / LOT 1100647816.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male