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	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later upon inspection, it was confirmed that the right cylinder had a tear, so the right cylinder and the pump were explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
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.D4.Concomitant product udi for pump is (b)(4).
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the inflatable penile prosthesis (ipp) underwent a comprehensive evaluation.The pump was microscopically inspected, functionally tested, and leak tested.Microscopic examination showed that the pump tubing had been cut down to the pump block; the tubing was returned attached to the cylinder.The other two kink resistant tubes (krts) were not returned.No leaks were identified, and the pump met the requirements of the functional test.The cylinder was microscopically inspected and leak tested.The first cylinder exhibited broken fabric threads and a detached outer sleeve due to wear in the middle portion of the cylinder, as well as a hole located at the corner of a fold in the same area.Leaks were identified at this location.Based on the available information and analysis results, the leak at the fold corner of the first cylinder confirms the reported clinical observations of device mechanical issue and cylinder hole/perforated.D4.Concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product did not work properly.Two weeks later upon inspection, it was confirmed that the right cylinder had a tear, so the right cylinder and the pump were explanted and replaced.No patient complications 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: 23548879
• Report Number: 2124215-2025-81599
• Device Sequence Number: 9457790
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)290416(10)1100493017
• 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: 2024
• 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): 01/22/2026

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 Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1100493017
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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: LOT: 1100499833 UPN 72404310 PUMP.; LOT: 1100499833 UPN 72404310 PUMP.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male