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

Model Number	72404437
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device performance allegations of auto inflation and deflation issues cannot be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced auto inflation and inability to deflate the device.During evaluation, the physician explanted and tested the system, confirming that it functioned properly outside the body.However, once reimplanted, the right cylinder slightly deflated, which the physician attributed to anatomical factors.The pump was subsequently replaced, and adjustments were made to the right corpora.The device then functioned as expected.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced auto inflation and inability to deflate the device.During evaluation, the physician explanted and tested the system, confirming that it functioned properly outside the body.However, once reimplanted, the right cylinder slightly deflated, which the physician attributed to anatomical factors.The pump was subsequently replaced, and adjustments were made to the right corpora.The device then functioned as expected.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for reservoir is (b)(4).Correction to field h7: if remedial act init, type.Correction to field h9: correction/removal reporting #.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced auto inflation and inability to deflate the device.During evaluation, the physician explanted and tested the system, confirming that it functioned properly outside the body.However, once reimplanted, the right cylinder slightly deflated, which the physician attributed to anatomical factors.The pump was subsequently replaced, and adjustments were made to the right corpora.The device then functioned as expected.There were no patient complications reported.

• Brand Name: AMS 700? CX 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: 22522726
• Report Number: 2124215-2025-47574
• Device Sequence Number: 20836011
• Product Code: JCW
• UDI-Device Identifier: 00191506021382
• UDI-Public: (01)00191506021382(17)260328(10)1100480290
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2026

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: 72404437
• Device Catalogue Number: 72404437
• Device Lot Number: 1100480290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/12/2025; 01/20/2026
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 09/10/2025; 01/22/2026
• 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-0143-2026
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UPN: 720185-01 LOT: 1100584179 - RESERVOIR; UPN: 720185-01 LOT: 1100584179 - RESERVOIR; UPN: 720185-01 LOT: 1100584179 - RESERVOIR
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male