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

Model Number	72404012
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product was not working properly.Two weeks later upon inspection, it was confirmed that the cylinder had a hole, so both cylinders and the pump were explanted and replaced.No patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) went to the hospital because the product was not working properly.Two weeks later upon inspection, it was confirmed that the cylinder had a hole, so both cylinders and the pump were explanted and replaced.No patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was visually inspected, functionally and leak tested.Under microscope observation, contamination (bodily fluid) was found within the ms pump.As a result, the functional test was not performed.No leaks were identified.The cylinders were visually inspected and leak tested.The first cylinder showed inner tube and fabric thread detachment in the proximal end consistent with sharp instrument damage, while the second cylinder had a hole and tool mark in the proximal end, also consistent with sharp instrument damage.The first cylinder did not pass the leak test, however the second cylinder did.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.The sharp instrument damage found on the device is considered a secondary failure, so the allegation of hole/perforate and mechanical issue were unable to be confirmed.D4.Concomitant product udi for pump is (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: 23825087
• Report Number: 2124215-2025-91329
• Device Sequence Number: 9288416
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)230103(10)1000027783
• 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: 2018
• 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): 02/27/2026

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: 01/03/2023
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 1000027783
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2018
• 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: LOT:1100632494 UPN:72404310; LOT:1100632494 UPN:72404310
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male