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

Model Number 72404233

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2018

Event Type  Injury  

Event Description

It was reported that the patient was unable to inflate the inflatable penile prosthesis(ipp) due suspected leak somewhere in the implant.Upon removal of the ipp, air was found inside the pump which confirmed the suspicion, but the location of the leak was not determined.No complications were reported in relation to this event.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8223198
• MDR Text Key: 132258539
• Report Number: 2183959-2019-60005
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003467
• UDI-Public: 00878953003467
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2009
• Device Model Number: 72404233
• Device Catalogue Number: 72404233
• Device Lot Number: 513730005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR