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

Model Number	72404155
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was no longer inflating.Additionally, air in the system was noted, along with fluid loss due to a hole in the reservoir hub.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4.Concomitant product udi for cylinders and pump is (b)(4).
Additional Manufacturer Narrative
D4.Concomitant product udi for cylinders and pump is (b)(4).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 middle of the cylinder.Both cylinders had wear at fold in the proximal end, middle, and distal end of the cylinder.The fist cylinder did not pass the leak test, however the second cylinder did.The reservoir was microscopically inspected, and leak tested.The microscope test revealed that the reservoir had wear at a fold in reservoir shell.No leaks were identified.Based on the information available and analysis results, the reported clinical observations of air in system/component, inflation issue, reservoir fluid leak, reservoir hole/perforated could not be confirmed; however, the cylinder not passing the microscopic and leakage tests could affect product performance.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was no longer inflating.Additionally, air in the system was noted, along with fluid loss due to a hole in the reservoir hub.The ipp was explanted and replaced.No patient complications were reported.

• 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: 22294529
• Report Number: 2124215-2025-40368
• Device Sequence Number: 20926315
• Product Code: JCW
• UDI-Device Identifier: 00878953003207
• UDI-Public: (01)00878953003207(17)180829(10)149215017
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 08/29/2018
• Device Model Number: 72404155
• Device Catalogue Number: 72404155
• Device Lot Number: 0149215017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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, CYLINDERS: UPN 72404252/ LOT 0156059002.; PUMP, CYLINDERS: UPN 72404252/ LOT 0156059002.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male