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

Model Number 720185-01

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Fever (1858); Fistula (1862); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Perforation (2001); Urinary Tract Infection (2120); Fluid Discharge (2686)

Event Date 09/15/2019

Event Type  Injury  

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) implant procedure and within fifteen days of discharge, the patient developed bleeding, redness, pain and fever.The patient was readmitted and found to have an urinary tract infection with scrotal wound drainage.A treatment of intra venous, and oral antibiotics was started after discharge.A month later, the patient underwent a removal procedure in which the existing pump was removed and replaced with a new one.During the procedure a small hole was found in the skin lying over the pump and a small fistula was also noted.The patient was discharged the same day and it is unclear if the ipp pump contributed to the event.It was also unclear if any device defect was identified.Additional information received.The infection was located in the patient's scrotum.The pump was moved to the opposite side.

Manufacturer Narrative

B5, h2, h6, h10 updated.

Event Description

It was reported that the patient underwent an inflatable penile prosthesis (ipp) implant procedure and within fifteen days of discharge, the patient developed bleeding, redness, pain and fever.The patient was readmitted and found to have an urinary tract infection with scrotal wound drainage.A treatment of intra venous, and oral antibiotics was started after discharge.A month later, the patient underwent a removal procedure in which the existing pump was removed and replaced with a new one.During the procedure a small hole was found in the skin lying over the pump and a small fistula was also noted.The patient was discharged the same day and it is unclear if the ipp pump contributed to the event.It was also unclear if any device defect was identified.Additional information received.The infection was located in the patient's scrotum.The pump was moved to the opposite side.Additional information received indicated that the patient experienced cellulitis within fifteen days of implant procedure.The drainage was not purulent.

• 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
• MDR Report Key: 9528571
• MDR Text Key: 174461009
• Report Number: 2183959-2019-68356
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005669
• UDI-Public: 00878953005669
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2021
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1000320682
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 78