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	09/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4).And for reservoir 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, a crack was found in the cylinder connecting tube, so both cylinders were 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, a crack was found in the cylinder connecting tube, so both cylinders were replaced.No patient complications reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, the inflatable penile prosthesis (ipp) cylinders underwent a detailed analysis, including microscopic inspection and leak testing.Microscopic examination revealed wear at the folds in both the proximal and distal ends of the cylinders.No leaks were identified during testing.Based on the available information and analysis results, the reported clinical observations of tube hole/perforated and device mechanical issue were not confirmed.

• 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: 23293449
• Report Number: 2124215-2025-72750
• Device Sequence Number: 4890014
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)280322(10)1100278180
• 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): 12/29/2025

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: 1100278180
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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:1100380265 UPN:72404161; LOT:1100380265 UPN:72404161; LOT:1100437339 UPN:72404310; LOT:1100437339 UPN:72404310
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male