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

Model Number	72404458
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
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 this inflatable penile prosthesis (ipp) presented to clinic with complaint of device not easily inflating and deflating.As a result, the pump was explanted and replaced.No patient complications 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 this inflatable penile prosthesis (ipp) presented to clinic with complaint of device not easily inflating and deflating.As a result, the pump was explanted and replaced.No patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to clinic with complaint of device not easily inflating and deflating.As a result, the pump was explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was visually and microscopically inspected where no damage or abnormalities were found.The pump underwent leakage test where a normal size stream flowed out of the left cylinder kink resistant tubing (krt), but the right cylinder krt flowed slower with less water.A functional test was performed, but it did not pass the deflation test.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, the difficult to deflate and device difficult to inflate observations were most likely determined to be due to the over insertion of the krt into the pump block; therefore, a conclusion code of quality control deficiency was assigned to this investigation.Model number/catalog number: 720185-01, batch/lot number: 1100670123, model/catalog description: reservoir flat iz 100 ml, unique identifier (udi) #: (b)(4).

• 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: 23809770
• Report Number: 2124215-2025-90922
• Device Sequence Number: 12684167
• Product Code: JCW
• 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: 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 Model Number: 72404458
• Device Catalogue Number: 72404458
• Device Lot Number: 1100658995
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2025
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 08/21/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/29/2026; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR || 1100670123 UPN: 720185-01.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male