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

Model Number	72404434
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Inflation Problem (1310)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complications using their inflatable penile prosthesis (ipp) implant device and the device was attempted to be used by the patient following activation, both the patient and physician identified that the pump was not functioning properly for sufficient inflation and use.Scar tissue made it difficult to pump.No air was observed, there were no holes observed in the system, and the pump did not stay flat.The most likely/suspected cause of the customer reported issue was an overly sensitive pressure relief mechanism, and the scar tissue described most likely developed after the previous implantation.Additionally, there was a potential slight right cylinder buckling in the distal corpora.The physician removed and replaced the cylinder and pump through replacement surgery with a new cylinder/pump system connected to the existing reservoir, and there were no further signs or symptoms reported.
Additional Manufacturer Narrative
D10: concomitant product udi for reservoir is (b)(4).H6: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptom(s) are known risk associated with this device type and indicated as such in the instructions for use.
Additional Manufacturer Narrative
Model number/catalog number: 720185-01 serial number: n/a batch/lot number: 1100747978 model/catalog description: reservoir flat iz 100 ml unique identifier (udi) #: (b)(4).Corrected the adverse event/product problem field (b1) in section b, adverse event/product problem.Corrected the concomitant medical products and therapy dates field (d10) in section d, suspect medical device.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The microscopic visual inspection of the cylinders revealed that the first cylinder had a hole in the proximal end of the cylinder from sharp instrument damage which is standard for the explant process.The second cylinder passed microscopic visual inspection with no damage or abnormalities found.The leakage test of the cylinders revealed that the first cylinder had a leak from the sharp instrument damage in the proximal end of the cylinder.The second cylinder passed the leakage test.The functional test of the pump revealed that the pump failed valve de-active state testing.The passed leakage testing and microscopic visual inspection with no damage or abnormalities found.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the events of scarring, mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) and bond separation were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Bond separation, scarring, difficult to inflate, and inflation issue are acknowledged within the instructions for use (ifu) and is not related to off label use or failure to follow instructions.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation as the pump difficult to inflate and pump inflation issue was most likely determined to be the pump failure of the valve de-active state test from the functional test performed and the analysis of the available information.The bond separation could not be substantiated during functional testing, and no other fault conditions were identified.The sharp instrument damage on the first cylinder probably occurred during the explant surgery and will be considered a secondary failure.
Event or Problem Description
It was reported that the patient complications using their inflatable penile prosthesis (ipp) implant device and the device was attempted to be used by the patient following activation, both the patient and physician identified that the pump was not functioning properly for sufficient inflation and use.Scar tissue made it difficult to pump.No air was observed, there were no holes observed in the system, and the pump did not stay flat.The most likely/suspected cause of the customer reported issue was an overly sensitive pressure relief mechanism, and the scar tissue described most likely developed after the previous implantation.Additionally, there was a potential slight right cylinder buckling in the distal corpora.The physician removed and replaced the cylinder and pump through replacement surgery with a new cylinder/pump system connected to the existing reservoir, and there were no further signs or symptoms 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 ; +1(508)652-1217
• MDR Report Key: 23775410
• Report Number: 2124215-2025-90307
• Device Sequence Number: 10170275
• Product Code: JCW
• UDI-Device Identifier: 00191506021351
• UDI-Public: (01)00191506021351(17)270530(10)1100737778
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404434
• Device Catalogue Number: 72404434
• Device Lot Number: 1100737778
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2025
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male