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

Model Number 72401464

Device Problems Break (1069); Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Scarring (2061)

Event Date 01/01/2010

Event Type  Injury  

Event Description

It was reported that the patient experienced mechanical issues with an ultrex inflatable penile prosthesis (ipp) eight years ago.A replacement surgery was performed in which the existing cylinders and pump were removed and replaced, and the reservoir was not explanted from the body.A new ipp system was implanted.The patient did not experience further complications.It was further reported that during the procedure it was noticed that the right cylinder had a break in the out layer of silicone leading to tissue in-growth in the dacron fiber middle layer resulting in fluid loss.The exact onset of the issues was unknown but was said to be around fifteen years after the implant date.The patient did not experience any further adverse events and was said to have no complications following the procedure.No more information available at the moment.Should additional information become available, it will be provided.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 9826351
• MDR Text Key: 183259419
• Report Number: 2183959-2020-01244
• Device Sequence Number: 1
• Product Code: FHW
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72401464
• Device Catalogue Number: 72401464
• Device Lot Number: AU079010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR