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

Model Number UNK-P-IPP

Device Problems Break (1069); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was confirmed via product analysis.The cylinders returned cut in half.Product analysis identified a fluid leak in the body of cylinder 2 along with holes in the outer tubes of both cylinders.The fluid leak was attributed to input tube wear and fatigue.The holes in the outer tube were also attributed to input tube wear.This damage would affect the functionality of the device and would therefore be the most probably cause for the reported events.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

It was reported that the patient underwent a removal of an inflatable penile prosthesis (ipp) device which was implanted back in 1995.The removal for the device was due to cylinder rupture on both sides.So both cylinders had ruptured and all the fluid had leaked out so the device failed.The doctor removed the device and replaced it with a malleable tactra penile prosthesis device.The reason for this revision was device malfunction.The patient is doing well.No more information available.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9613161
• MDR Text Key: 175852256
• Report Number: 2183959-2020-00183
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR