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

Catalog Number 72403337

Device Problems Deflation Problem (1149); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 02/24/2018

Event Type  Injury  

Manufacturer Narrative

Reservoir 100 ml iz component - catalog # 549509007; expiration date: 06/09/2010; serial # (b)(4).

Event Description

It was reported the patient had his inflatable penile prosthesis removed and replaced due to malfunction.The physician reported that when inflating the pump, "it collapses, has no stiffness for penetration." the physical examination showed that when the pumping mechanism (was) activated, the pump collapsed.No patient complications were reported in relation to this event.Additional information received reported the patient experienced fluid loss due to pump rupture.There were no patient complications reported as a result of this event.This complaint was initially submitted to fda via asr report q1 2018 and additional information was received by boston scientific.Due to the removal of exemption e1997037, this information is provided via supplemental report.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 8262600
• MDR Text Key: 133689527
• Report Number: 2183959-2019-00008
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2013
• Device Catalogue Number: 72403337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR