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

Model Number	72404289
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, used the first day of the aware month.
Event or Problem Description
It was reported that the patient was expected to have the inflatable penile prosthesis replaced due to a right cylinder aneurysm.There were no patient complications reported.
Event or Problem Description
It was reported that the patient had the inflatable penile prosthesis revised due to a right cylinder aneurysm and to repair the tunica due to the right cylinder bulging.No further information was provided.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: unknown, used the first day of the aware month.

• 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; two scimed place; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16343333
• Report Number: 2124215-2023-05541
• Device Sequence Number: 12370251
• Product Code: FHW
• UDI-Device Identifier: 00878953003924
• UDI-Public: 00878953003924
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/21/2022
• Device Model Number: 72404289
• Device Catalogue Number: 72404289
• Device Lot Number: 1000028437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male