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

Model Number 72404232

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 12/29/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the device no longer inflating as a result of fluid loss causing the cylinder rupture to form a hole in both cylinders.The ipp cylinder, pump, and reservoir was explanted and replaced with a new ipp cylinder, pump, and reservoir.There were no patient complications reported.

Manufacturer Narrative

The ams 700 momentary squeeze (ms) pump was visually inspected.The kink resistant tubing (krt) was worn to the filament; however, no leaks were present.The contamination was found inside pump.The pump was not functionally tested due to contamination.The ams700 ipp cylinders were visually inspected and functionally tested.Cylinder 1 had a leak in proximal cylinder body that was the result of sharp instrument damage consistent with explant damage; hole was present.Due to this damage being consistent with explant it will be considered a secondary failure.Cylinder 2 had bulging when inflated in proximal cylinder body.Both cylinders had broken fabric threads and a large hole with avulsion in the outer tube attributed to wear against the krt.The krt of both cylinders were worn to filament.Both cylinders were not pressure test due to bulge and leak were identified.

Event Description

It was reported that the patient underwent a surgical procedure to revise this inflatable penile prosthesis (ipp) due to the device no longer inflating as a result of fluid loss causing the cylinder rupture to form a hole in both cylinders.The ipp cylinder, pump, and reservoir was explanted and replaced with a new ipp cylinder, pump, and reservoir.There were no patient complications reported.

• 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: 11178850
• MDR Text Key: 227080980
• Report Number: 2183959-2020-06390
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003450
• UDI-Public: 00878953003450
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2019
• Device Model Number: 72404232
• Device Catalogue Number: 72404232
• Device Lot Number: 1000001399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR