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

Model Number 72404251

Device Problems Failure to Cycle (1142); Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Related components of device system: model number/ catalog number: 720185-01.Serial number: n/a.Batch/ lot number: 924864007.Model/ catalog description: reservoir flat iz 100 ml.

Event Description

It was reported that patient underwent a replacement procedure of his inflatable penile prosthesis (ipp).Over past several months, patient states the implant slowly quit pumping.All components removed and replaced.Explants will not be returned.Left cylinder had a leak.The outer sheath of the cylinder was torn resulting in fluid leak.Other components appeared ok.No adverse patient effects.

• 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 ; 4089353452
• MDR Report Key: 9528498
• MDR Text Key: 174461067
• Report Number: 2183959-2019-68359
• 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: 12/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72404251
• Device Catalogue Number: 72404251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• 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: 54 YR