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

Model Number	72404014
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	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the right cylinder connecting tube.The right cylinder and the pump were explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient visited the hospital because his inflatable penile prosthesis (ipp) was not functioning properly.The patient underwent surgery two weeks later and upon inspection, a crack was identified in the right cylinder connecting tube.The right cylinder and the pump were explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The first cylinder was microscopically inspected and leak tested.Microscopic examination identified a hole in the kink resistant tubing consistent with fatigue.Wear was observed at the fold locations in the proximal, middle, and distal regions of the cylinder.Leakage testing confirmed fluid loss from the first cylinder.The pump was microscopically inspected, leak tested and functionally tested.The pump tubing was cut down to the pump block, and the tubing for the first cylinder was returned attached to the cylinder; the tubing for the other cylinder and reservoir was not returned for analysis.Leakage and functional testing were successfully completed without abnormalities.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.A risk review was completed and confirmed that the events of "mechanical malfunction (leaks, incomplete inflation/ deflation, kinking)" and "excess force or friction on silicone leads to stress, strains, holes or tears" were defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the available test results and investigation, product analysis was able to confirm the reported mechanical issue and tubing hole/perforation, which is most likely attributed to fatigue of the first cylinder kink resistant tubing.A conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 23882963
• Report Number: 2124215-2025-92806
• Device Sequence Number: 9622618
• Product Code: JCW
• UDI-Device Identifier: 00878953002712
• UDI-Public: (01)00878953002712(17)230503(10)1000099777
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 05/03/2023
• Device Model Number: 72404014
• Device Catalogue Number: 72404014
• Device Lot Number: 1000099777
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PUMP: UPN: 72404310 / LOT: 1100087951; PUMP: UPN: 72404310 / LOT: 1100087951
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male