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

Model Number	72404282
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	10/02/2023
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 with this inflatable penile prosthesis (ipp) experienced infection, redness and swelling in the scrotum.One week later, a surgical procedure was performed to remove the device and, postoperatively, the patient was treated with antibiotics and anti-inflammatory medication.There were no further patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) underwent a thorough analysis.Both cylinders were visually inspected, and leak tested.No visual damage or abnormalities were noted, no leaks were identified in the cylinders.The pump was visually inspected, leak and functionally tested.No visual damage or abnormalities were noted, no leaks were identified; however, the pump did not pass activation test during the functional inspection.The reservoir was visually inspected, and leak tested.No damage or abnormalities were noted, no leaks were identified in the component.The reported patient symptoms of infection, swelling, skin inflammation and purulent discharge are a known risk associated with implant of these device 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 with this inflatable penile prosthesis (ipp) experienced infection, redness, swelling and pus discharge in the scrotum.One week later, a surgical procedure was performed to remove the device and, postoperatively, the patient was treated with antibiotics and anti-inflammatory medication.There were no further patient complications 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: 18020595
• Report Number: 2124215-2023-59908
• Device Sequence Number: 6642707
• Product Code: FHW
• UDI-Device Identifier: 00878953003856
• UDI-Public: 00878953003856
• 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
• Report Date (Section B): 12/20/2023

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: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1100272848
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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: 1000349806; RESERVOIR: UPN: 72404161 / LOT: 1000349806
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG