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

Model Number	72404302
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited fluid leakage due to damage in the left cylinder.A revision surgery was performed to explant and replace the device.No further details were provided.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The cylinder was visually inspected and underwent leak testing.The kink resistant tubing (krt) was worn to the filament.The cylinder had a hole in the outer tube from krt wear in the proximal end which led to fluid leakage.In addition, an unused cylinder was returned for analysis, no visual abnormalities were found, and it did pass leak testing.Based on the information available and analysis results, the hole found in the cylinder could have caused or contributed to the reported clinical observation of mechanical issue; therefore, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) exhibited fluid leakage due to damage in the left cylinder.A revision surgery was performed to explant and replace the device.No further details were provided.

• 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: 18320972
• Report Number: 2124215-2023-70777
• Device Sequence Number: 7316052
• Product Code: FHW
• UDI-Device Identifier: 00878953005737
• UDI-Public: 00878953005737
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1100059728
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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: RESERVOIR: UPN: 72404161 / LOT: 1100053477; RESERVOIR: UPN: 72404161 / LOT: 1100053477
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male