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

Model Number	72404272
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	01/14/2026
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 crack in the cylinder connecting tube was found.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
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.D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (b)(4).
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 crack in the cylinder connecting tube was found.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (b)(4).Upon receipt at our quality assurance laboratory, this device underwent a thorough analysis.The cylinders, pump and reservoir were microscopically examined, and leak tested.Testing of the cylinders revealed holes and tool marks in the proximal end of the cylinder from sharp instrument, and leaks from these sharp instrument.Additionally, one of the cylinders had wear at the fold in the proximal end and middle of the cylinder, meanwhile the other cylinder had wear at the fold in the proximal end of the cylinder.Regarding the momentary squeeze (ms) pump, under microscope observation contamination (bodily fluid) was found within the pump, and the kink resistant tubing (krt) were worn to the filament; the ms pump passed leakage test.Finally, regarding the spherical reservoir, it was observed to had wear at a fold in reservoir shell; the component passed leakage testing.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.A risk review was completed and confirmed that the event of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) 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 this investigation a clear probable cause for the event cannot be established.

• 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
• MDR Report Key: 24279352
• Report Number: 2124215-2026-06842
• Device Sequence Number: 9802840
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)230708(10)1000131373
• 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: 2018
• 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,Followup
• Report Date (Section B): 04/10/2026

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: 07/08/2023
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 1000131373
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2018
• 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: PUMP: UPN 72404310 / LOT 1000084737; PUMP: UPN 72404310 / LOT 1000084737; RESERVOIR: UPN 72404161 / LOT 1000073491; RESERVOIR: UPN 72404161 / LOT 1000073491
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male