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

Model Number 72401451

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Material Puncture/Hole (1504); Insufficient Information (3190)

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

Event Date 12/17/2019

Event Type  Injury  

Event Description

It was reported that the ambicor penile prosthesis (app) device was explanted due to unspecified reasons.A new 16cm x 12.5mm app device was implanted.

Manufacturer Narrative

Additional information received clarified that this report is a duplicate event and is reported under mfr# 2183959-2019-66138 and the analysis will be submitted after completion under mfr# 2183959-2019-66138.

Event Description

It was reported that the ambicor penile prosthesis (app) device was explanted due to unspecified reasons.A new 16cm x 12.5mm app device was implanted.This report is a duplicate event and is reported under mfr# 2183959-2019-66138 and the analysis will be submitted after completion under mfr# 2183959-2019-66138.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9647694
• MDR Text Key: 176988083
• Report Number: 2183959-2020-00356
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953000954
• UDI-Public: 00878953000954
• 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: 02/21/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2007
• Device Model Number: 72401451
• Device Catalogue Number: 72401451
• Device Lot Number: 347374004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR