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

Model Number 72404310

Device Problem Collapse (1099)

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

Event Date 08/06/2019

Event Type  Injury  

Event Description

It was reported that the patient had the inflatable penile prosthesis pump component removed due to a dimpled pump.A new inflatable penile prosthesis pump 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 the patient pressed the pump, but the it stayed flat.The specific cause was not found.The onset of the event was 2 weeks ahead of the surgery.The patient outcome was reported as the patient got well.

Event Description

It was reported that the patient had the inflatable penile prosthesis pump component removed due to a dimpled pump.A new inflatable penile prosthesis pump 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 the patient pressed the pump, but the it stayed flat.The specific cause was not found.The onset of the event was 2 weeks ahead of the surgery.The patient outcome was reported as the patient got well.

Manufacturer Narrative

H3 device evaluation: the complaint component was returned and analyzed.The reported allegation of pump malfunction was confirmed via product analysis of the pump.The pump failed the 8 lb.Activation test.The pump required more than 8 lbs.Of force to activate.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: 8954099
• MDR Text Key: 156271393
• Report Number: 2183959-2019-65951
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/15/2023
• Device Model Number: 72404310
• Device Catalogue Number: 72404310
• Device Lot Number: 1000193531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Date Manufacturer Received: 10/08/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR