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

Model Number	72404011
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) developed an infection.The ipp was explanted, and at a later date, a new ipp was implanted.There were no additional patient complications reported.
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.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 with this inflatable penile prosthesis (ipp) developed an infection.The ipp was explanted, and at a later date, a new ipp was implanted.There were no additional patient complications reported.
Additional Manufacturer Narrative
Upon receipt of the inflatable penile prosthesis (ipp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Both cylinders presented wear at the folds at the proximal end of the body.The cylinders also had holes in the proximal ends, consistent with sharp instrument damage, resulting in fluid leaks.One of the cylinders had broken fabric threads from the sharp instrument damage.The kink resistant tubing (krt) from both cylinders and the pump was worn to the filament.The pump failed the activation testing that was performed.A risk review was performed and confirmed that infection is known adverse event with this device.Based on the information available, infection is a known risk with the device and the issues identified could affect product functionality.

• 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: 18956423
• Report Number: 2124215-2024-16765
• Device Sequence Number: 19961579
• Product Code: FHW
• UDI-Device Identifier: 00878953002682
• UDI-Public: 00878953002682
• 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: 2021
• Device Explanted Year: 2021
• 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): 05/14/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/05/2025
• Device Model Number: 72404011
• Device Catalogue Number: 72404011
• Device Lot Number: 1000441937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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#: 1000485872; PUMP: UPN: 72404310 LOT#: 1000485872; RESERVOIR: UPN: 720182-01 LOT#: 1000375012; RESERVOIR: UPN: 720182-01 LOT#: 1000375012
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Male