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

Model Number 72404252

Device Problems Failure to Cycle (1142); Fluid/Blood Leak (1250); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced unspecified performance issues with his ams device.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.The ams 700 momentary squeeze (ms) pump was visually inspected; no leaks were found.The kink resistant tubing (krt) was worn to filament; no leak was found.Therefore, this wear would not affect the functionality of the device.The pump was functional test and performed within specification.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 an inflatable penile prosthesis (ipp) procedure due to the device was not cycling.Upon removal, a fluid leak in the tubing was identified.Cylinders and pump were removed and replaced.

• 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: 10254355
• MDR Text Key: 198317817
• Report Number: 2183959-2020-02854
• Device Sequence Number: 1
• Product Code: FHW
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2018
• Device Model Number: 72404252
• Device Catalogue Number: 72404252
• Device Lot Number: 0144021002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Date Manufacturer Received: 07/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR