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

Model Number 72404257

Device Problems Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2018

Event Type  Injury  

Event Description

It was reported that the patient was scheduled for a replacement of his inflatable penile prosthesis (ipp) because the doctor suspected there was fluid loss from the system.When the patient was in the operating room a second doctor performed a function test on the ipp and determined the device was working perfectly.During the testing he was able to determine there was an air bubble in the pump.After cycling the device several times they were able to work the air bubble out of the pump.No further surgery was required and the patient's ipp remains implanted.

Event Description

It was reported that the patient was scheduled for a replacement of his inflatable penile prosthesis (ipp) because the doctor suspected there was fluid loss from the system.The patient was not able to inflate his implant by himself.When the patient was in the operating room a second doctor performed a function test on the ipp and determined the device was working perfectly.During the testing he was able to determine there was an air bubble in the pump.After cycling the device several times they were able to work the air bubble out of the pump.No further surgery was required and the patient's ipp remains implanted.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: mike bocchino ; 10700 bren road w; minnetonka, MN 55343 ; 6515827161
• MDR Report Key: 7985827
• MDR Text Key: 124378695
• Report Number: 2183959-2018-60325
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003658
• UDI-Public: 00878953003658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2019
• Device Model Number: 72404257
• Device Catalogue Number: 72404257
• Device Lot Number: 1000028840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR