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

Model Number	72404302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Itching Sensation (1943); Swelling/ Edema (4577)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient presented an infection after the implant of an inflatable penile prosthesis (ipp) device.The device was explanted, and no further patient complications were reported in relation to this event.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient described feeling swollen and itchy due to an infection after the implant of an inflatable penile prosthesis (ipp) device.The device was explanted, and no further patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.The pump and cylinders were visually inspected and underwent leak and microscopical testing.No visual damages were found in neither of the components upon inspection.Both components passed the leak testing.The reservoir was visually inspected and underwent leak and microscopical testing.No visual damages were found.The reservoir passed leak testing.Rear tip extenders were visually inspected and microscopically examined; however, no damages were found upon inspection.Based on the information available and analysis results, device performance did not likely cause or contribute to the reported patient symptom which is a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Therefore, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient described feeling swollen and itchy due to an infection after the implant of an inflatable penile prosthesis (ipp) device.The device was explanted, and no further 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17682282
• Report Number: 2124215-2023-47792
• Device Sequence Number: 16796595
• Product Code: FHW
• UDI-Device Identifier: 00878953005737
• UDI-Public: 00878953005737
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/28/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 72404302
• Device Catalogue Number: 72404302
• Device Lot Number: 1100070742
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 09/27/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/12/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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: 720182-01 UPN: / LOT: 1100127235.; RESERVOIR: 720182-01 UPN: / LOT: 1100127235.; RESERVOIR: 720182-01 UPN: / LOT: 1100127235.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 70 KG