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

Model Number	72404273
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
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 a surgery was performed, as a result of the inspection, it was confirmed that the cylinder was broken.The ipp was explanted and replaced.There were not patient complications.
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4).
Additional Manufacturer Narrative
D4.Concomitant product udi for pump is (b)(4) and for reservoir is (b)(4).Correction to field g2: report source.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump was microscopically inspected, functionally and leak tested.The microscope test revealed that the pump kink resistant tubing (krt) were worn to the filament.The pump passed functional testing.No leaks were identified.The cylinders were microscopically inspected, and leak tested.The microscope test found that the first cylinder had a hole at corner of a fold in the distal end of the cylinder.Also, the second cylinder had a hole at corner of a fold in the proximal end of the cylinder.Both cylinders had buckling folds in the middle of the cylinder and had wear at fold in the proximal end and distal end of the cylinder.Leaks were identified.The reservoir was microscopically inspected, and leak tested.The microscope test identified that the reservoir had wear at a fold in reservoir shell and krt was worn to the filament.No leaks were identified.Based on the information available and analysis results, the hole and leak identified in both cylinders confirmed the reported clinical observations of device not working properly and cylinder broken.
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 a surgery was performed, as a result of the inspection, it was confirmed that the cylinder was broken.The ipp was explanted and replaced.There were not patient complications.

• Brand Name: AMS 700 CX
• 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: 21858225
• Report Number: 2124215-2025-23995
• Device Sequence Number: 11942473
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)211120(10)154679002
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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 Expiration Date: 11/20/2021
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 0154679002
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2016
• 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 0157432002.; PUMP UPN 72404310 / LOT 0157432002.; RESERVOIR UPN72404161 /LOT 0156779014.; RESERVOIR UPN72404161 /LOT 0156779014.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male