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

Model Number	72404011
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	12/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product udi for 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's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed during which was identified a hole in the left cylinder.The left cylinder and the pump were replaced.No patient complications were reported.
Event or Problem Description
It was reported that the patient's inflatable penile prosthesis (ipp) was not functioning properly.A surgical procedure was performed during which was identified a hole in the left cylinder.The left cylinder and the pump were replaced.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1100190596.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 cylinder was visually inspected and leak tested.Visual inspection revealed broken fabric threads caused by wear, as well as a hole in the outer tube due to fatigue at the proximal end of the cylinder.The leak test confirmed fluid leakage through the broken fabric threads and the fatigued outer tube in the proximal area.The pump was visually inspected, leaked and functionally tested.Visual inspection showed that the ms pump tubing had been cut down to the pump block; the tubing itself was not returned for analysis.The ms pump passed the leak test.However, during functional testing, the ms pump did not pass activation tests 2 and 3.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 hole/perforate, fluid leak and mechanical issue 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 and analysis results, the fluid leak due to fabric wear and outer tube fatigue identified in the cylinder could have caused or contributed to the reported clinical observation of hole/perforate and mechanical issue.Additionally, the pump not passing the functional test, could affect product performance.Therefore, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 24046958
• Report Number: 2124215-2026-01955
• Device Sequence Number: 18578255
• Product Code: JCW
• UDI-Device Identifier: 00878953002682
• UDI-Public: (01)00878953002682(17)250323(10)1000416126
• 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: 2023
• 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): 03/13/2026

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: 03/23/2025
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1000416126
• 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: 12/21/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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: 1100190596
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male