MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 INFLATABLE PENILE PROSTHESIS WITH TENACIO PUMP; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72404420
Medical Device Problem Codes	Collapse (1099); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump of this inflatable penile prosthesis (ipp) was not inflating the device.The pump would not pump and stay depressed.Troubleshooting measures were performed but were unsuccessful.The ipp is currently implanted.There were no patient complications reported.

• Brand Name: AMS 700 INFLATABLE PENILE PROSTHESIS WITH TENACIO PUMP
• 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: 20231052
• Report Number: 2124215-2024-57840
• Device Sequence Number: 8162827
• Product Code: FHW
• UDI-Device Identifier: 00191506021290
• UDI-Public: 00191506021290
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 72404420
• Device Catalogue Number: 72404420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/16/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White