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

Model Number	72404272
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	04/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a tear in the cylinder was identified.All the components were removed and replaced.The cause of the cylinder tear was not detailed by the hospital.There were no patient complications reported.
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir is (b)(4).Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders and rear tip extenders (rte) were visually inspected, and leak tested.The rtes passed the visual inspection.No damage or abnormalities were found.The first cylinder had a hole in the outer tube from wear in the proximal end of the cylinder.The first cylinder had broken fabric threads from wear in the proximal end of the cylinder.The first cylinder had a leak from wear in the proximal end of the cylinder.The second cylinder passed both visual inspection and leakage test.The pump was visually inspected, leak and functionally tested.Under microscope observation, contamination (bodily fluid) was found within the pump.The pump passed the leakage test.To avoid damaging the test equipment, the pump was not functionally tested.The reservoir was visually inspected, and leak tested.The reservoir had wear at a fold in reservoir shell.The reservoir passed the leakage test.Based on the information available and analysis results, the reason for mechanical issue and hole/perforation was most likely determined to be the wear in the proximal end of the first cylinder.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a tear in the cylinder was identified.All the components were removed and replaced.The cause of the cylinder tear was not detailed by the hospital.There were no patient complications reported.

• 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: 22134102
• Report Number: 2124215-2025-36081
• Device Sequence Number: 7487104
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)221009(10)189190007
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 10/09/2022
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 0189190007
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• 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: 1000094883.; PUMP: UPN: 72404310 / LOT: 1000094883.; RESERVOIR: UPN: 72404161 / LOT: 1000105377.; RESERVOIR: UPN: 72404161 / LOT: 1000105377.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male