MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 CXR; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404012
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed during which was identified a hole in the right cylinder.The right cylinder and the pump were replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).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 pump is (b)(4).Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The cylinder was microscopically inspected and leak tested.Inspection revealed a hole at the corner of a fold in the proximal end, broken fabric threads from wear, and additional wear at folds in the proximal, middle, and distal sections.Leak testing confirmed a leak at the same location.The pump was microscopically inspected, leaked and functionally tested.Microscopic inspection revealed scaling on the pump block.Functional testing did not pass in activation tests 2 and 3, while the leak test passed.Based on the available information and analysis results, the hole and leak in the cylinder, could have caused or contributed to the reported clinical observations of cylinder hole/perforation and device mechanical issue.Additionally, pump scaling and the pump not reaching the activation test specifications could affect product performance.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.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed during which was identified a hole in the right cylinder.The right cylinder and the pump were replaced.No patient complications were reported.

• 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: 23381336
• Report Number: 2124215-2025-76134
• Device Sequence Number: 12959476
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)201118(10)112643003
• 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: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 11/18/2020
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 112643003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PUMP: UPN: 72404310 / LOT: 121146002.; PUMP: UPN: 72404310 / LOT: 121146002.; RESERVOIR: UPN: 72404161 / LOT: 122530010.; RESERVOIR: UPN: 72404161 / LOT: 122530010.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male