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

Model Number	72404282
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Swelling/ Edema (4577)
Date of Event	11/15/2023
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 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 implant site of this inflatable penile prosthesis (ipp) was itchy, swollen and red due to an infection.The device was explanted.No further patient complications were reported.
Event or Problem Description
It was reported that the implant site of this inflatable penile prosthesis (ipp) was itchy, swollen and red due to an infection.The device was explanted.No further patient complications were 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 underwent leak testing.No visual damages nor abnormalities were found; in addition, both cylinders passed leak testing.The pump was visually inspected and underwent leak and functional testing.The pump passed visual inspection and leak testing; however, it did not pass activation testing.The reservoir was visually inspected and underwent leak testing.No visual damages nor abnormalities were found in the reservoir, and it did pass leak testing.In addition, the rear tip extenders (rte) were visually inspected.However, no visual damages nor abnormalities were found.Based on the information available and analysis results, device performance did not likely cause or contribute to the reported patient symptoms of infection, swelling, itching, and inflammation which are 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.

• 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: 18232087
• Report Number: 2124215-2023-66834
• Device Sequence Number: 6936498
• 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): 02/05/2024

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 Model Number: 72404282
• Device Catalogue Number: 72404282
• Device Lot Number: 1100272843
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/05/2024
• 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: 1000349835; RESERVOIR: UPN: 72404161 / LOT: 1000349835
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 76 KG