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

Model Number 72404310

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

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

Event Date 06/21/2019

Event Type  Injury  

Event Description

It was reported that the patient had the inflatable penile prosthesis pump component removed due to disorder.A new inflatable penile prosthesis pump component was implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated that when the patient pressed the pump, but the it stayed flat resulting in a dimpled pump.The event occurred 2 weeks ahead of the surgery.

Event Description

It was reported that the patient had the inflatable penile prosthesis pump component removed due to disorder.A new inflatable penile prosthesis pump component was implanted.Further information was requested and not yet received.Should additional relevant details become available, a supplemental report will be submitted.Additional information received indicated that when the patient pressed the pump, but the it stayed flat resulting in a dimpled pump.The event occurred 2 weeks ahead of the surgery.

Manufacturer Narrative

D10, h3, h6, h10 h3 device evaluation: the complaint component was returned and analyzed.The reported allegation of malfunction was not confirmed via product analysis of the pump.No leak was found.The pump performed functional testing within specifications.No escalation to ncep, capa, or scar is required.

• Brand Name: AMS INFLATABLE 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: 8765816
• MDR Text Key: 150237342
• Report Number: 2183959-2019-64808
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003986
• UDI-Public: 00878953003986
• 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: 09/19/2019

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: 03/12/2023
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000071526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/06/2019
• Supplement Dates Manufacturer Received: 09/19/2019
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR