MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72404293
Medical Device Problem Codes	Collapse (1099); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis did not work as expected.Two weeks later, the inflatable penile prosthesis pump and cylinder were removed and replaced as the pump was dimpled when the pump was pressed.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of this inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders were visually inspected, and leak tested.Both cylinders had wear at a fold in the middle of the cylinder.Both cylinders passed the leakage test.The pump was visually inspected, leak tested, and functionally tested.The kink resistant tubing (krt) between the pump and reservoir was trimmed close to pump block; the tubing was not returned for analysis.The pump passed the leak test.The pump did not pass the activation testing.Based on the information available and analysis results, the mechanical issue was confirmed with a conclusion code of cause was traced to component failure.
Event or Problem Description
It was reported that the patient was seen by the physician as the inflatable penile prosthesis did not work as expected.Two weeks later, the inflatable penile prosthesis pump and cylinder were removed and replaced as the pump was dimpled when the pump was pressed.No patient complications were reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: 18477107
• Report Number: 2124215-2023-75699
• Device Sequence Number: 15152009
• Product Code: FHW
• UDI-Device Identifier: 00878953003955
• UDI-Public: 00878953003955
• 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: 2021
• Device Explanted Year: 2023
• 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): 03/26/2024

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: 72404293
• Device Catalogue Number: 72404293
• Device Lot Number: 0187825010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2017
• 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 1000584940; PUMP UPN 72404310 LOT 1000584940; RESERVOIR UPN 72404161 LOT 1000264758; RESERVOIR UPN 72404161 LOT 1000264758
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male