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

Model Number	72404301
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with this implant that was no longer deflating resulting in pain.There has been no surgical intervention at this time, and there were no additional patient complications reported.
Additional Manufacturer Narrative
Updated d4 model number, catalog number, and unique identifier.
Event or Problem Description
It was reported that the patient presented with this implant that was no longer deflating resulting in pain.There has been no surgical intervention at this time, and 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 and pump were visually inspected, and leak tested.There were no abnormalities, and the components passed leak testing.The pump was functionally tested and did not pass the deflation tests.Based on the information available, the reported device allegation was confirmed.
Event or Problem Description
It was reported that the patient presented with this inflatable penile prosthesis (ipp) that was no longer deflating resulting in pain.The ipp was explanted, and there were no additional 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: 19234474
• Report Number: 2124215-2024-26892
• Device Sequence Number: 15169779
• Product Code: FHW
• UDI-Device Identifier: 00878953005720
• UDI-Public: 00878953005720
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 09/23/2024

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: 72404301
• Device Catalogue Number: 72404301
• 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: 04/14/2024
• Supplement Date Received by Manufacturer: 08/09/2024; 09/05/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 08/30/2024; 09/23/2024
• 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: Other
• Patient Sex: Male