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

Model Number	72404155
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Discomfort (2330)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced erosion and discomfort as the reservoir herniated and extruded to the abdomen.A surgical procedure was performed to remove and replace the device.There were no further patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this inflatable penile prosthesis (ipp) reservoir underwent a thorough analysis.The component was visually and microscopically inspected, and leak tested.Wear at fold in its shell was noted; however, no leaks were identified.The reported patient symptoms of discomfort, erosion, extrusion and reservoir migration are known risks associated with implant of these device as indicated in the instructions for use (ifu).Per gfe, it was indicated that this event and surgery occurred two hours after the first intervention previously reported in 2124215-2021-25807.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) experienced erosion and discomfort as the reservoir herniated and extruded to the abdomen.A surgical procedure was performed to remove and replace the component.There were no further patient complications reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• 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: 20438348
• Report Number: 2124215-2024-63726
• Device Sequence Number: 8406049
• Product Code: FHW
• UDI-Device Identifier: 00878953003207
• UDI-Public: 00878953003207
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: 72404155
• Device Catalogue Number: 72404155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown