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

Model Number 72404253

Device Problems Inflation Problem (1310); Difficult or Delayed Activation (2577)

Patient Problem No Information (3190)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Model number: 72404253, serial number: (null), lot number: 103752005, model description: lgx preconnect ms 21cm ps, iz, implant date: (b)(6) 2015, explant date: (b)(6) 2018, expiration date: 09/22/2017, manufacture date: 10/08/2015, (b)(4).Model number: 72404134, serial number: (null), lot number: 923910008, model description: belt cuff fgs, 6.0 cm, iz, implant date: (b)(6) 2015.Explant date: (b)(6) 2018, expiration date: 02/24/2016, manufacture date: 03/10/2015, (b)(4).

Event Description

It was reported that the patient's inflatable penile prosthesis pump component collapsed and would not activate after using the deflate button.The patient saw their physician and reported the collapsed pump and that the problem has progressively gotten worse over the last few weeks.The patient tried to re-cycle the pump using the deflate button and had some success but again experienced issues activating.No additional patient complications were reported in relation to this event.It was subsequently reported the implant was removed an replaced due to pump failure and sticky pump.This complaint was initially submitted to fda via asr report q3 2016 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: 8081583
• MDR Text Key: 127533653
• Report Number: 2183959-2018-00128
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003610
• UDI-Public: (01)00878953003610(11)151008(17)170922(10)103752005
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2017
• Device Model Number: 72404253
• Device Catalogue Number: 72404253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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: 72 YR