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

Model Number	72404012
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	10/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For the concomitant components: this product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.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 tear in the cylinder was identified.The cause of the cylinder tear was not detailed by the hospital.All the components were removed and replaced.No patient complications were reported.
Additional Manufacturer Narrative
For the concomitant components: this product was manufactured prior to implementation of the udi regulation and as a result, the complete udi is not available.Applicable us product data has been included in this report.Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinders were microscopically inspected and tested for leaks.The first cylinder had broken fabric threads from wear in the proximal end of the cylinder.The first cylinder had wear at fold in the proximal end and middle of the cylinder.The first cylinder had a bulge in the proximal end of the cylinder when inflated with syringe.The second cylinder had a hole at corner of a fold in the proximal end of the cylinder.The second cylinder had wear at fold in the proximal end and middle of the cylinder.The second cylinder had broken fabric threads from wear in the proximal end of the cylinder.The second cylinder had a leak from the hole found.The second cylinder had a bulge when inflated with syringe.The pump was microscopically inspected and tested for leaks.The pump had kink resistant tubing (krt) worn to filament; outer layer of pump bulb worn from wear against the pump strain relief krt junction.No leaks were found in the pump.The reservoir was microscopically inspected and tested for leaks.The reservoir had wear at a fold in reservoir shell.The reservoir krt had a hole from fatigue.The reservoir krt had a leak from fatigue.Based on the information available and analysis results, the reason for the cylinder hole/perforation and the mechanical issue was most likely determined to be the second cylinder leak from the corner of a fold.Both cylinders had bulging which would contribute to the device mechanical issue allegation.Additionally, the hole and leak found in the reservoir could affect the product performance.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.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
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 tear in the cylinder was identified.The cause of the cylinder tear was not detailed by the hospital.All the components were removed and replaced.No patient complications were reported.

• Brand Name: AMS 700 CXR
• 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: 23760667
• Report Number: 2124215-2025-88225
• Device Sequence Number: 15981975
• Product Code: JCW
• UDI-Device Identifier: 00878953002699
• UDI-Public: (01)00878953002699(17)190825(10)898762001
• 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: 2022
• Device Explanted Year: 2025
• 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): 02/27/2026

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: 08/25/2019
• Device Model Number: 72404012
• Device Catalogue Number: 72404012
• Device Lot Number: 898762001
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2014
• 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: 72401110 / LOT: 811880006; PUMP: UPN: 72401110 / LOT: 811880006; RESERVOIR: UPN: 72404161 / LOT: 905013013; RESERVOIR: UPN: 72404161 / LOT: 905013013
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male