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

Model Number 72404238

Device Problems Collapse (1099); Inflation Problem (1310); Defective Device (2588)

Patient Problem Capsular Contracture (1761)

Event Date 01/07/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced inflation issues for six months with an inflatable penile prosthesis (ipp) due to a sticky pump.The physician tried to inflate the device around twenty times by resetting the pump, it would pop and function as normal but around the fifth time of doing the sequence it would "dimple" again.A revision surgery was performed in which the existing device was removed and a new ipp was implanted.During the procedure a pseudocapsule was removed.The capsule was due to how the patient healed with the previous device.There were no further patient complications related to the device and the patient was said to e healing following the procedure.

Event Description

It was reported that the patient experienced inflation issues for six months with an inflatable penile prosthesis (ipp) due to a sticky pump.The physician tried to inflate the device around twenty times by resetting the pump, it would pop and function as normal but around the fifth time of doing the sequence it would "dimple" again.A revision surgery was performed in which the existing device was removed and a new ipp was implanted.During the procedure a pseudocapsule was removed.The capsule was due to how the patient healed with the previous device.There were no further patient complications related to the device and the patient was said to e healing following the procedure.

Manufacturer Narrative

Product investigation completed.Product analysis confirmed a pump collapse based on the identification of a pump functional activation test failure.The pump failed the 8lb.Activation test and therefore required more than 8lbs.Of force to activate.This functional test failure aligns with the event details relating to the pump requiring additional force to inflate.Therefore, product analysis confirmed pump collapse, but unable to confirm the reported allegations related to capsular contracture.Based on the results of this investigation, no escalation is required.

• 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: 10332050
• MDR Text Key: 200599814
• Report Number: 2183959-2020-03210
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003511
• UDI-Public: 00878953003511
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2021
• Device Model Number: 72404238
• Device Catalogue Number: 72404238
• Device Lot Number: 1000230120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Date Manufacturer Received: 09/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR