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

Model Number 72404253-12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Hematuria (2558)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that the reservoir of this recently implanted inflatable penile prosthesis (ipp) eroded into the bladder of the patient, who was urinating blood.A revision surgery was performed and the reservoir was explanted and replaced.No additional patient complications were reported.

Event Description

It was reported that the reservoir of this recently implanted inflatable penile prosthesis (ipp) eroded into the bladder of the patient, who was urinating blood.A revision surgery was performed and the reservoir was explanted and replaced.No additional patient complications were reported.

Manufacturer Narrative

There was no device available for analysis and there was no report of a device performance allegation.The reported patient symptoms of erosion and hematuria are known risk associated with this type of implant and indicated as such in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14493204
• MDR Text Key: 292575137
• Report Number: 2124215-2022-18048
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009827
• UDI-Public: 00878953009827
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/24/2023
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1000573036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RESERVOIR UPN:72404155, LOT:889691004; RESERVOIR UPN:72404155, LOT:889691004
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Male