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

Model Number 720185-01

Device Problems Failure to Cycle (1142); Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 09/21/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to the device not working and the pump stayed flat with an inflatable penile prosthesis (ipp).After several attempts to get the pump to work the physician decided to replace the reservoir and following connecting the device the device cycled properly.

Event Description

It was reported that the patient underwent a revision procedure due to the device not working ad the pump stayed flat with an inflatable penile prosthesis (ipp).After several attempts to get the pump to work the physician decided to replace the reservoir and following connecting the device the device cycled properly.The physician also identified kinked tubing.

• 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: 10697297
• MDR Text Key: 211888061
• Report Number: 2183959-2020-04812
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005669
• UDI-Public: 00878953005669
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: 11/24/2021
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1000358589
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR