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

Model Number	72404453
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented with inflation issues.It was noted there was fluid loss due to the left cylinder was broken and frayed.The ipp was removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ipp pump and cylinders underwent a thorough analysis.The components were visually and microscopically examined, and leak tested; the pump was also functionally tested.Visual and microscopic examination of the cylinders revealed that there was a hole due to wear in the outer tube in the distal part of one of the cylinders, and there was a hole at the corner of a fold in the distal end; due to these holes, it was also observed that the cylinder did not pass leak testing.The other cylinder had wear at fold in the distal end, it passed leak testing.Regarding the pump, it was identified that id did not pass activation test.Based on the information available and analysis results, it was confirmed the reported observations of hole/perforated and fluid leak.Additionally, these observations and the activation problems from the pump, could have caused or contributed to the reported clinical observation of inflation problem.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented with inflation issues.It was noted there was fluid loss due to the left cylinder was broken and frayed.The ipp was removed and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Updated product investigation summary: upon receipt at our quality assurance laboratory, this ipp pump and cylinders underwent a thorough analysis.The components were visually and microscopically examined, and leak tested; the pump was also functionally tested.Visual and microscopic examination of the cylinders revealed that there was a hole due to wear in the outer tube in the distal part of one of the cylinders, and there was a hole at the corner of a fold in the distal end; due to these holes, it was also observed that the cylinder did not pass leak testing.The other cylinder had wear at fold in the distal end, it passed leak testing.Regarding the pump, it was identified that it passed visual inspection, functional, and leak test.Based on the information available and analysis results, it was confirmed the reported observations of hole/perforated and fluid leak could have caused or contributed to the reported clinical observation of inflation problem.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented with inflation issues.It was noted there was fluid loss due to the left cylinder was broken and frayed.The ipp was removed 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: 21275666
• Report Number: 2124215-2025-04589
• Device Sequence Number: 8533071
• Product Code: JCW
• UDI-Device Identifier: 00191506021443
• UDI-Public: (01)00191506021443(17)260614(10)1100530701
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 06/14/2026
• Device Model Number: 72404453
• Device Catalogue Number: 72404453
• Device Lot Number: 1100530701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 04/08/2025; 06/16/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 05/02/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male