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

Model Number 72404233

Device Problems Collapse (1099); Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2020

Event Type  Injury  

Event Description

It was reported that an inflatable penile prosthesis (ipp) pump was revised due to the pump not working during activation for the second time.It was explained that the device cycled fine on the operating room table, but again did not work during activation.This patient was referred for advanced troubleshooting with the medical education team, but the issue is still apparent.No patient complications were related to this event.

• 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
• 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: 10756579
• MDR Text Key: 213711482
• Report Number: 2183959-2020-05223
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003467
• UDI-Public: 00878953003467
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2020
• Device Model Number: 72404233
• Device Catalogue Number: 72404233
• Device Lot Number: 1000120809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention