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	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for pump is (b)(4).Concomitant product udi for reservoir 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 crack in the cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.All the components were removed 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 crack in the cylinder connecting tube was identified.The cause of the crack in the connecting tube was not detailed by the hospital.All the components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
Correction to field b1: adverse event/product problem.Model number/catalog number: 72404310, serial number: n/a, batch/lot number: 1000146757, model/catalog description: pump ms, unique identifier (udi)#: (b)(4), model number/catalog number: 72404161, serial number: n/a, batch/lot number: 1000174115, model/catalog description: reservoir 65ml pc, unique identifier (udi)#: (b)(4).Upon receipt at our quality assurance laboratory, the cylinders and pump of this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks and pressure.Both cylinders had holes in the outer sleeve from kink resistant tubing (krt) wear in the proximal end of the cylinder.Both cylinders had wear at fold in the proximal end and middle of the cylinder.Both cylinders had broken fabric threads from wear in the proximal end.No leaks were found in the cylinders.Both cylinders passed the pressure test.The ms pump was microscopically inspected and tested for leaks.It was not functionally tested due to bodily fluid contamination identified within it.Microscope examination revealed that the pump krt had a hole from fatigue at the strain relief junction.The pump krt had a leak from fatigue at the strain relief junction.Based on the information available and analysis results, the reason for the mechanical issue and the tubing hole/perforation was most likely determined to be a hole/leak from fatigue in the krt connecting to the cylinder.The fluid loss from the pump krt tubing would result in a mechanical issue because if any part of the system leaks, the devices can no longer maintain pressure and will not function correctly when the pump is activated.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 excess force or friction on silicone leads to stress, strains, holes or tears 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 information available, a 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: 23381859
• Report Number: 2124215-2025-76330
• Device Sequence Number: 18403623
• Product Code: JCW
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 05/10/2023
• Device Model Number: 72404272
• Device Catalogue Number: 72404272
• Device Lot Number: 1000100007
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2018
• 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: 1000146757.; PUMP: UPN: 72404310 / LOT: 1000146757.; RESERVOIR: UPN: 72404161 / LOT: 1000174115.; RESERVOIR: UPN: 72404161 / LOT: 1000174115.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male