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

Model Number	72404156
Medical Device Problem Codes	Nonstandard Device (1420); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product information for preconnect: model number/catalog number: 72404432, serial number: n/a, batch/lot number: 1100771773, model/catalog description: cx preconnect tenacio 18cm ps, iz, unique identifier (udi): (b)(4).
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) was pressing on the patient's iliac vein.As a result, the reservoir was explanted and replaced with a conceal low-profile reservoir.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product information for preconnect: model number/catalog number: 72404432.Serial number: n/a.Batch/lot number: 1100771773.Model/catalog description: cx preconnect tenacio 18cm ps, iz.Unique identifier (udi): (b)(4).Upon receipt at our quality assurance laboratory, this reservoir underwent a thorough analysis.The reservoir was visually and microscopically inspected, and leak tested.Inspection revealed that the reservoir kink resistant tubing (krt) was cut apart in two places form sharp instrument damage, while reservoir itself passed visual inspection, no damage or abnormalities were found, the leak test passed.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.The device instructions for use (ifu) was reviewed.The reported reservoir migration was found to be listed in the ifu.A risk review was completed and confirmed that the event of migration was defined in the product risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the reservoir of this inflatable penile prosthesis (ipp) was pressing on the patient's iliac vein.As a result, the reservoir was explanted and replaced with a conceal low-profile reservoir.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: 24551817
• Report Number: 2124215-2026-12960
• Device Sequence Number: 18512994
• Product Code: JCW
• UDI-Device Identifier: 00878953003214
• UDI-Public: (01)00878953003214(17)270630(10)1100753188
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 04/08/2026

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: 72404156
• Device Catalogue Number: 72404156
• Device Lot Number: 1100753188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male