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

Model Number 72404252

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

It was reported that during preparation, the inflatable penile prosthesis(ipp)pump in the cylinders failed by the nurse on the back table.There were no patient complications reported in relation to the device.

Manufacturer Narrative

The ams700 ipp cylinders were visually inspected and functionally tested; no leaks were found.The cylinders were pressure tested and performed within specification.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The pump poppet rod was identified to be misaligned.This displacement or misalignment is indicative of simultaneous compression of the deflation button and the pump bulb.Excessive physical manipulation can damage internal components resulting in component separation or misalignment and subsequent loss of inflation and deflation capabilities.The product record review indicated that the reported events do not represent an unanticipated event.Review of the manufacturing documentation confirmed all required in-process and final inspections and testing were completed.The investigation conclusion code of failure to follow instructions was chosen as the damage observed can be traced to the user not following the manufacturers instructions.

Event Description

It was reported that during preparation, the inflatable penile prosthesis(ipp)pump in the cylinders failed by the nurse on the back table.There were no patient complications reported in relation to the device.

• 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: 10390697
• MDR Text Key: 202382774
• Report Number: 2183959-2020-03468
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2021
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 1000345476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 12/18/2020
• Patient Sequence Number: 1