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

Model Number 72404252

Device Problems Failure to Cycle (1142); Fluid/Blood Leak (1250)

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

Event Date 12/23/2019

Event Type  Injury  

Event Description

It was reported that the patient stated that when he inflated his inflatable penile prosthesis, the pump will go flat after about 8 pumps and will stay flat and that he needs to push the deflate button to get the pump to refill.He states that it has worked fine for the past 4 years and that this is a new onset over the past few days.Patient services specialist recommended to reset his pump (from the trouble shooting guide) and that he push the deflate button before attempting to inflate (then with a hard, fast vigorous pump on the initial pump).The patient said that he will try these maneuvers and will contact his md if he does not have success.

Event Description

It was reported that the patient stated that when he inflated his inflatable penile prosthesis, the pump will go flat after about 8 pumps and will stay flat and that he needs to push the deflate button to get the pump to refill.He states that it has worked fine for the past 4 years and that this is a new onset over the past few days.Patient services specialist recommended to reset his pump (from the trouble shooting guide) and that he push the deflate button before attempting to inflate (then with a hard, fast vigorous pump on the initial pump).The patient said that he will try these maneuvers and will contact his md if he does not have success.It was further reported that all components were removed and replaced due to fluid loss at the reservoir.The patient had a good outcome and fully recovered.

• 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
• MDR Report Key: 9586137
• MDR Text Key: 174887948
• Report Number: 2183959-2020-00073
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003603
• UDI-Public: 00878953003603
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2016
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 902701005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR