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

Model Number 72401450

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2020

Event Type  malfunction  

Event Description

It was reported that the during replacement procedure of another manufacturer device, the ambicor penile prosthesis (app) that they tried was malfunctioning, it would not pump completely.

Manufacturer Narrative

The complaint component was returned and analyzed, and the reported allegation was not confirmed via product analysis.The ambicor cylinders were visually inspected; as confirmed during receiving, the ambicor did not have any air in the system.No leaks nor abnormalities were identified; product analysis was unable to confirm the reported events.Based on the results of this investigation, no escalation is required.

Event Description

It was reported that the during replacement procedure of another manufacturer device, the ambicor penile prosthesis (app) that they tried was malfunctioning, it would not pump completely.Additional information was received.Device was only pumped 1 and a half times and the pump never re-filled.

• 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: 9908261
• MDR Text Key: 188481295
• Report Number: 2183959-2020-01782
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953000947
• UDI-Public: 00878953000947
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: 72401450
• Device Catalogue Number: 72401450
• Device Lot Number: 1000190999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/15/2020
• Patient Sequence Number: 1
• Patient Age: 76 YR