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

Model Number	72404013
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	12/10/2025
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 hole in the left cylinder was found.The left cylinder, pump and reservoir were removed and replaced, while the existing reservoir was kept in the patient.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (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 this inflatable penile prosthesis (ipp) was not performing as expected.Two weeks later a revision surgery was performed, upon examination a hole in the left cylinder was found.The left cylinder, pump and reservoir were removed and replaced, while the existing reservoir was kept in the patient.No patient complications were reported.
Additional Manufacturer Narrative
Model number/catalog number: 72404161.Serial number: n/a.Batch/lot number: 1000159781.Model/catalog description: reservoir.D4 unique identifier (udi) for reservoir: (b)(4).Model number/catalog number: 72404310.Serial number: n/a.Batch/lot number: 1000115325.Model/catalog description: pump.D4 unique identifier (udi) for reservoir: (b)(4).Updated concomitant product comment.Upon receipt at our post market quality assurance laboratory, the returned cylinder and momentary squeeze (ms) pump were thoroughly analyzed.The cylinder was microscopically inspected and leak tested; it was found broken fabric threads from wear, a hole from fatigue associated with a bulge, and wear at folds in the proximal, middle, and distal ends of the cylinder.Additionally, it was observed that the cylinder had buckling folds and a bulge due to excess air between inner and outer tubes when inflated with syringe.The cylinder did not pass the leakage testing due to the leak found from fatigue in the proximal end of the cylinder.The ms pump was microscopically inspected; and leak and functionally tested.The tubing was cut down to the pump block.The ms pump passed the leakage and functional 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) and inconsistent cylinder diameter (aneurysm) 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 the information available and analysis results, the hole and leak identified in one of the cylinders could have caused or contributed to the reported clinical observation of mechanical problem, and it confirmed the reported cylinder hole.

• 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: 24096666
• Report Number: 2124215-2026-03239
• Device Sequence Number: 10243530
• Product Code: JCW
• UDI-Device Identifier: 00878953002705
• UDI-Public: (01)00878953002705(17)221003(10)187769010
• 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
• 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): 03/16/2026

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: 10/03/2022
• Device Model Number: 72404013
• Device Catalogue Number: 72404013
• Device Lot Number: 0187769010
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2017
• 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: UPN 72404310 / LOT 1000115325; RESERVOIR: UPN 72404161 / LOT 1000159781
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male