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

Model Number 72404209

Device Problems Collapse (1099); Fluid/Blood Leak (1250)

Patient Problem Pain (1994)

Event Date 02/24/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced sudden pain in the right scrotum during intercourse and then after that the inflatable penile prosthesis device would no longer work.He reported to surgeon on (b)(6) 2020.The event happened approximately one week prior to this consultation.The physician indicated the cause of the malfunction was fluid loss as the device would not work and the pump stayed flat.Revision surgery is booked for (b)(6) 2020.

• 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 west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 10105025
• MDR Text Key: 193035969
• Report Number: 2183959-2020-02366
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003351
• UDI-Public: 00878953003351
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2019
• Device Model Number: 72404209
• Device Catalogue Number: 72404209
• Device Lot Number: 0178963005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL # 72404156LOT # 1000030064; MODEL # 72404172LOT # 173610003
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR