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	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (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.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the right cylinder was found.The ipp was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the right cylinder was found.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
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.Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 0174270003.Model/catalog description: reservoir 65ml pc.Unique identifier (udi) #: (b)(4).Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 0179253006.Model/catalog description: pump ms.Unique identifier (udi) #: (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The microscopic visual inspection of the cylinder revealed that the first cylinder had wear at a fold in the proximal end, middle, and distal end of the cylinder, and a hole at a corner of a fold in the proximal end of the cylinder.The second cylinder had wear at a fold in the proximal end and middle of the cylinder.The microscopic visual inspection of the spherical reservoir revealed that the reservoir had wear at a fold in the reservoir shell.The pump passed the microscopic visual inspection.The leakage test of the cylinder revealed that the first cylinder had a leak at a corner of a fold in the proximal end of the cylinder.The reservoir, second cylinder, and pump passed the leakage test.The functional test of the pump revealed that the pump failed inflation test.The device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the events of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) and device has a fluid leak were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Mechanical issue and cylinder hole 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 cylinder hole/perforation and device mechanical issue was most likely determined to be the leak at the corner of a fold in cylinder 1 from the functional test performed and the analysis of the available information.The fluid loss from cylinder 1 and failure of the pump that did not pass inflation test would result in a mechanical issue because if any part of the system leaks, the devices can no longer maintain pressure and will not function correctly when the pump is activated.

• 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 ; 5086521217
• MDR Report Key: 24533652
• Report Number: 2124215-2026-12628
• Device Sequence Number: 10350516
• Product Code: JCW
• 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: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: 02/06/2022
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 0164236003
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• 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 0179253006.; PUMP: UPN 72404310 / LOT 0179253006.; RESERVOIR: UPN 72404161 / LOT 0174270003.; RESERVOIR: UPN 72404161 / LOT 0174270003.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male