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

Model Number	72404161
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	05/27/2025
Type of Reportable Event	Serious Injury
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 hole in the reservoir was identified.The cause of the hole was not detailed by the hospital.All the components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for cylinders is (b)(4).Concomitant product udi for pump 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 hole in the reservoir was identified.The cause of the hole was not detailed by the hospital.All the components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product udi for cylinders is (b)(4).Concomitant product udi for pump 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 reservoir was microscopically inspected and tested for leaks.Microscope examination revealed that the reservoir wear at a fold in reservoir shell.No leaks were found in the reservoir.The cylinders were microscopically inspected and tested for leaks.Microscope examination revealed that the first cylinder had a hole at corner of a fold in the proximal end of the cylinder.The first cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.The first cylinder had a leak at corner of a fold in the proximal end of the cylinder.The second cylinder had wear at fold in the proximal end, middle, and distal end of the cylinder.No leaks were found in the second cylinder.The pump was microscopically inspected, leak and functionally tested.Microscope examination revealed that the pump kink resistant tubing (krt) were worn to the filament.No leaks were found in the pump.The pump did not pass the activation test.Based on the information available and analysis results; the reported allegations of mechanical issue and hole/perforation are unable to be confirmed.However, a conclusion code of cause traced to component failure was assigned to this investigation, because the leak found in the first cylinder and the pump not passing the activation test could affect product performance.

• Brand Name: AMS 700 SPHERICAL RESERVOIR
• 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: 22377632
• Report Number: 2124215-2025-43414
• Device Sequence Number: 20826194
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)220522(10)175642009
• 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: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 05/22/2022
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 0175642009
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2017
• 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: CYLINDERS: UPN: 72404292 / LOT: 0145442002; CYLINDERS: UPN: 72404292 / LOT: 0145442002; PUMP: UPN: 72404310 / LOT: 0179253003; PUMP: UPN: 72404310 / LOT: 0179253003
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male