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	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for cxr 16cm is (b)(4).Udi field (d4) concomitant product udi for pump is (b)(4).
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the reservoir had a hole.Cylinders and pump were removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.There were no patient complications.
Event or Problem Description
It was reported that a patient with an inflatable penile prosthesis (ipp) presented with a nonfunctioning device.A revision surgery was performed, during which the physician confirmed that the reservoir had a hole.Cylinders and pump were removed and replaced, while the existing reservoir was kept in the patient and a new one was added to the system.There were no patient complications.
Additional Manufacturer Narrative
Udi field (d4) concomitant product udi for cxr 16cm is (b)(4).Udi field (d4) concomitant product udi for pump is (b)(4).Upon receipt at the quality assurance laboratory, the returned first cylinder, second cylinder, and ms pump underwent evaluation.Microscope inspection of the first cylinder revealed wear at the fold in the proximal end and middle, three holes from sharp instrument damage located at the proximal, middle, and distal ends, and tool marks in the middle; the leakage test did not pass the test due to these holes.The second cylinder showed a hole in the proximal end from a sharp instrument and wear at the fold in the proximal and middle areas; it also showed leakage at the proximal end from sharp instrument damage.Microscope inspection of the ms pump indicated kink resistant tubing (krt) was worn to the filament, and the pump passed the leak test; however, functional testing resulted in the ms pump failed activation tests 2 and 3.The reservoir was not available for analysis, so no physical evaluation could be performed, and the reported allegations of hole/perforation and mechanical issue cannot be confirmed.Based on the device history record (dhr), the reservoir and ms pump met specifications prior to shipment, indicating manufacturing was not related to the reported event.Given the absence of the returned reservoir and available information, a clear probable cause cannot be established; therefore, the conclusion code cause not established was assigned.

• 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: 22282399
• Report Number: 2124215-2025-39434
• Device Sequence Number: 18361683
• Product Code: JCW
• UDI-Device Identifier: 00878953003238
• UDI-Public: (01)00878953003238(17)230904(10)1000151401
• 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: 2019
• 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): 11/07/2025

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: 09/04/2023
• Device Model Number: 72404161
• Device Catalogue Number: 72404161
• Device Lot Number: 1000151401
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• 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: CXR 16CM LOT 1100247831, UPN 72404013.; CXR 16CM LOT 1100247831, UPN 72404013.; PUMP MS 1100222480, UPN 72404310.; PUMP MS 1100222480, UPN 72404310.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male