MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; prosthesis, penis, inflatable

Model Number	72404014
Medical Device Problem Codes	Degraded (1153); Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) was not functioning.A revision procedure was performed, during which it was confirmed that the right cylinder had a bulge.All components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this ipp underwent a thorough analysis.The cylinders, pump and reservoir were visually and microscopically inspected, and leak tested; the pump was also functionally tested.Microscopic examination of the cylinders revealed that both of them had wear at fold in the proximal end, middle and distal end of the component.Leakage testing of one of the cylinders noted a bulge when inflated with syringe.Regarding the pump, no anomalies were found under microscope or during leakage testing; however, it did not pass the activation tests when attempted.Finally, for the reservoir, it was identified wear at a fold in the shell, but no issues when leak tested.The device history record (dhr) review was unable to be performed as the lot number was not provided.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 review of the ams 700 hazard analysis was completed and confirmed that the events of mechanical problem and cylinder bulge were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the activation problems identified in the pump, and the bulging observed in the cylinders could have caused or contributed to the reported clinical observations.This record was identified during a retrospective review of complaint events; an electronic medical device report (emdr) was not previously submitted per applicable reporting criteria.Boston scientific has opened a nonconforming events and prevention investigation ((b)(4)) to determine the potential cause for why an emdr was not previously submitted to the food and drug administration (fda) in accordance with boston scientific's established medical device reporting process and fda adverse event reporting requirements.Information gained through these investigation efforts will be utilized to take action(s), as necessary.Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1000173239.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 1000168996.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).

• Brand Name: AMS 700 CXR
• 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: 50843216
• Report Number: 2124215-2026-50235
• Device Sequence Number: 18707981
• Product Code: JCW
• UDI-Device Identifier: 00878953002712
• UDI-Public: (01)00878953002712(17)230906(10)1000159364
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 09/06/2023
• Device Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1000159364
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2018
• 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: Hospitalization; Required Intervention
• Patient Sex: Male