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

Model Number 72404232-10

Device Problems Mechanical Problem (1384); Defective Device (2588)

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

Event Date 12/01/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure involving an inflatable penile prosthesis (ipp) and an artificial urinary sphincter (aus) due to the tubing from both systems had "grown together" and needed to be separated.Patient indicated being concerned because the physician left both pumps in the same place, but at the time everything was normal.The patient further reported having difficulty pumping the ipp as the bulb was too hard.Patient liaison went over reboot techniques including burping and anti stiction.Additional information was requested, however, no further information was available.Should additional information become available, it will be provided.

• 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: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 9639122
• MDR Text Key: 177856339
• Report Number: 2183959-2020-00288
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009780
• UDI-Public: 00878953009780
• 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
• Report Date: 01/28/2020

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: 07/07/2021
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1000299544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR