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); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) presented a mechanical problem, it was reported a fluid loss in the reservoir.The ipp was explanted and replaced.There were no patient complications reported.
Additional Manufacturer Narrative
Updated describe event or problem b5 and concomitant product/therapy c2/d10.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.We are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Both cylinders were microscopically inspected and leak testing.It was found buckling folds in the proximal end of the cylinder.Both cylinders passed the leakage test.Momentary squeeze (ms) pump was microscopically inspected, and it was found to have worn down to the filament.Ms pump passed leak testing.Finally, ms pump did not pass activation test.Regarding the spherical reservoir, it was microscopically inspected and leak testing.Spherical reservoir passed visual inspection and leakage test.Risk review and labeling review identified that the adverse event of leak are known risk of device.A most probable conclusion of cause traced to component failure was selected based on the activation problems found in the ms pump.Additionally, for the reported fluid leak, a conclusion of unable to exclude device problem was selected, as the reported fluid leak cannot be identified, since the connecting tubing was not returned for analysis.
Event or Problem Description
It was reported that the pump for this inflatable penile prosthesis (ipp) presented a mechanical problem, it was also reported that there was a fluid loss in the reservoir.The ipp was explanted and replaced.There were no patient complications 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: 22135103
• Report Number: 2124215-2025-34460
• Device Sequence Number: 8391588
• Product Code: JCW
• UDI-Device Identifier: 00878953003207
• UDI-Public: (01)00878953003207(17)230330(10)1000550628
• Combination Product (Y/N): Y
• Initial Reporter Country: TU
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 03/30/2023
• Device Model Number: 72404155
• Device Catalogue Number: 72404155
• Device Lot Number: 1000550628
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: CX PRECONNECT MS 18CM IP IZ: UPN 72404237
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male