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

Catalog Number 72404252

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

An analysis was performed and the results are as follows: the ams700 device was visually inspected.There was a hole in the outer tube of both cylinders that was the result of input tube wear and input sleeve wear.One cylinder had a leak in the inner tube due to input tube wear.This cylinder also had broken fabric threads.The pump was not functionally tested due to the cylinder leak.

Event Description

It was reported that the patient had his ams700 inflatable penile prosthesis cylinders and pump replaced due to fluid loss.Both cylinders were torn and leaking.This complaint was initially submitted to fda via asr report q3 2018 and additional information was received by boston scientific.Due to the removal of exemption e1997037, this information is provided via supplemental report.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 8041085
• MDR Text Key: 126217078
• Report Number: 2183959-2018-00125
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003603
• UDI-Public: 00878953003603
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970012
• 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: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2014
• Device Catalogue Number: 72404252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR