MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX? TENACIO? Pump; prosthesis, penis, inflatable

Model Number	72404451
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) tenacio pump, exhibited inflation and deflation issues.A surgical procedure was performed to replace the device.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).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.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).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.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) tenacio pump, exhibited inflation and deflation issues.A surgical procedure was performed to replace the device.No patient complications were reported.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) tenacio pump, exhibited inflation and deflation issues.A surgical procedure was performed to replace the device.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field c2/d10: concomitant product/therapy (0) correction to field h11: concomitant information model number/catalog number: 72404155.Serial number: n/a.Batch/lot number: 1100642639.Model/catalog description: reservoir.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, the pump underwent a thorough analysis.The pump was microscopically inspected, and leak and functionally tested.All tests passed.No damage or abnormalities were found.A computed tomography (ct) scan was performed, and the results indicated a reduced ability of the fluid to flow through the pump as designed due to the over insertion of one of the krts into the pump block.Despite the tenacio pump passing functional testing, the over insertion of the kink resistant tubing (krt) could cause pump deflation and inflation issues when the system is fully connected with cylinders and reservoir.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.A risk review was completed and confirmed that the event of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, a conclusion code of quality control deficiency was assigned to this investigation, as the cause of the pump inflation and deflation issue was confirmed to be over-insertion of both clear cylinder krts, as identified by the ct scan.

• 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: 23983537
• Report Number: 2124215-2026-00796
• Device Sequence Number: 10717647
• Product Code: JCW
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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
• 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): 09/17/2026

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: 03/28/2026
• Device Model Number: 72404451
• Device Catalogue Number: 72404451
• Device Lot Number: 1100480625
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 08/21/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 01/29/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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-0144-2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male