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	01/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4.Concomitant product udi for reservoir is (b)(4) and for the pump is (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.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a hole in the cylinder connecting tube was identified.As a result, the device was explanted and replaced.No patient complications were reported.
Event or Problem Description
It was reported that the patient went to the clinic because this inflatable penile prosthesis (ipp) was not working properly.Two weeks later, a surgical procedure was performed, during which a hole in the cylinder connecting tube was identified.The cause of the hole was not detailed by the hospital.As a result, the device was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Concomitant product information for reservoir: model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 1000105417.Model/catalog description: reservoir 65ml pc.Unique identifier (udi): (b)(4).Concomitant product information for pump: model number/catalog number:72404310.Serial number: n/a.Batch/lot number: 1000105185.Model/catalog description: pump ms.Unique identifier (udi): (b)(4).Upon receipt at our quality assurance laboratory, the returned components underwent a thorough analysis.The first cylinder was microscopically inspected and leak tested.Inspection revealed two holes at corners of two folds in the proximal end of the cylinder, along with wear at folds in the proximal end and middle of the cylinder.Leak testing confirmed a leak at corners of two folds in the proximal end of the cylinder.The second cylinder was microscopically inspected and leak tested.Inspection revealed a hole at corner of a fold in the proximal end of the cylinder, along with wear at fold in the proximal end and middle of the cylinder.Leak testing confirmed a leak at corner a fold in the proximal end of the cylinder.The pump was microscopically inspected, leaked and functionally tested.Microscopic inspection revealed that the ms pump kink resistant tubing (krt) were worn to the filament.Functional testing showed failure in activation tests, while the leak test passed.The reservoir was visually inspected and leak tested.Visual inspection revealed that the reservoir had wear at a fold in reservoir shell, while 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.A risk review was completed and confirmed that the events of mechanical malfunction (leaks, incomplete inflation/ deflation, kinking) and device has a fluid leak 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 the available information and analysis results, the leak in the cylinder, could have caused or contributed to the reported clinical observations of cylinder hole/perforation and device mechanical issue.Additionally, the pump not passing the functional test, could affect product performance.Therefore, the conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 24428413
• Report Number: 2124215-2026-09908
• Device Sequence Number: 10227197
• Product Code: JCW
• UDI-Device Identifier: 00878953003795
• UDI-Public: (01)00878953003795(17)221023(10)190653007
• 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,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 Expiration Date: 10/23/2022
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 0190653007
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2017
• 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 LOT: 1000105185, UPN: 72404310; RESERVOIR LOT: 1000105417, UPN: 72404161
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male