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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the reservoir was found.The pump was removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404310, serial number: n/a, batch/lot number: 1000584703, model/catalog description: pump ms, d4 unique identifier (udi): (b)(4).Model number/catalog number: 72404273, serial number: n/a, batch/lot number: 1000408452, model/catalog description: cx 18cm snap fit rt, d4 unique identifier (udi): (b)(4).The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available the cause that contributed to the reported event cannot be established.

• 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: 24988287
• Report Number: 2124215-2026-22438
• Device Sequence Number: 10505297
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)261101(10)1100042548
• 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: 2022
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 04/24/2026

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 Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 1100042548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 11/02/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male