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

Model Number 72404252

Device Problems Collapse (1099); Fluid/Blood Leak (1250)

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

Event Date 12/04/2017

Event Type  Injury  

Event Description

It was reported by the patient that the pump component of their inflatable penile prosthesis (ipp) was flat.The patient claimed that the pump flattened after pumping.The pump only refilled after the deactivation button was pressed.The patient suspected that their existing ipp may have lost some fluid.The aforementioned pump component was explanted and replaced on (b)(6) 2017.The explanted pump is expected to be returned.A supplemental report will be filed upon completion of the product analysis.

Event Description

It was reported that the patient underwent a surgical procedure to explant and replace the pump component of their inflatable penile prosthesis (ipp) as it remained flat after use.The pump was removed and a new pump implanted with the existing prosthesis.No patient complications were reported.Return of the explanted pump is not expected.A supplemental report will be filed should additional information received or the device returned for analysis.

• 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: 8532367
• MDR Text Key: 142517964
• Report Number: 2183959-2019-62386
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/11/2019
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 0168193003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR