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

Model Number	72404273
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: 72404310, serial number: n/a, batch/lot number: 0165744002, model/catalog description: pump ms, unique identifier (udi) #: (b)(4).Model number/catalog number: 72404161, serial number: n/a, batch/lot number: 0151589004, model/catalog description: reservoir 65ml pc, unique identifier (udi) #: (b)(6).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.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the events of non-functional device and cylinder tear were 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 a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented to the hospital with a non-functional device.Two weeks later, a surgical procedure was performed and upon inspection, there was a tear found in the left cylinder.As a result, the physician removed and replaced the entire device.The patient was stable following the procedure, and there were no patient complications reported.

• Brand Name: AMS 700 CX
• 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 ; 5086521217
• MDR Report Key: 25019450
• Report Number: 2124215-2026-22875
• Device Sequence Number: 21415747
• Product Code: JCW
• UDI-Device Identifier: 00878953003801
• UDI-Public: (01)00878953003801(17)220216(10)163685004
• 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: 2017
• Device Explanted Year: 2026
• 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): 07/06/2026

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: 02/16/2022
• Device Model Number: 72404273
• Device Catalogue Number: 72404273
• Device Lot Number: 0163685004
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 07/06/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male