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

Model Number	72404274
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	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (b)(4).
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 one cylinder was found.The ipp was explanted and replaced.No patient complications were reported.
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 one cylinder was found.The ipp was explanted and replaced.No patient complications were reported.
Additional Manufacturer Narrative
D4 unique identifier (udi) for reservoir: (b)(4).D4 unique identifier (udi) for pump: (b)(4).Upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Momentary squeeze (ms) pump was microscopically inspected, and it was found contamination (bodily fluid) was found within the ms pump.Ms pump passed the leakage test.Spherical reservoir was microscopically inspected, and it was found to had wear at a fold in reservoir shell.Spherical reservoir passed leak test.Finally, the cylinders were microscopically inspected, and it was found in the first cylinder wear at the fold in its midsection, a perforation in the outer tube due to abrasion from the input tubing, and frayed fabric threads near the proximal end.The tubing was eroded down to the filament.The first cylinder did not pass the leakage test due to a fluid leak from fatigue.The remaining cylinder showed wear at the fold near its distal end, along with a hole in the outer tube caused by abrasion from the input tubing at the proximal end.Additionally, frayed and broken fabric threads were observed in the area affected by the input tube.This cylinder passed the leakage test.Based on the available information and analysis results, the hole/perforate and mechanical problem in one of the cylinders could have caused or contributed to the reported clinical observation of mechanical problem.

• 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: 23033501
• Report Number: 2124215-2025-63981
• Device Sequence Number: 15907726
• Product Code: JCW
• UDI-Device Identifier: 00878953003818
• UDI-Public: (01)00878953003818(17)220131(10)162497002
• 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: 2017
• 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): 12/03/2025

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: 01/31/2022
• Device Model Number: 72404274
• Device Catalogue Number: 72404274
• Device Lot Number: 0162497002
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2017
• 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 0172146003; PUMP: UPN 72404310 / LOT 0172146003; RESERVOIR: UPN 72404161 / LOT 0164284001; RESERVOIR: UPN 72404161 / LOT 0164284001
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male