MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TACTRA MALLEABLE PENILE PROTHESIS; PROSTHESIS PENILE

Model Number 720080-01

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

Patient Problem Perforation (2001)

Event Date 10/03/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent surgical intervention to implant an inflatable penile prosthesis (ipp).During the procedure, the cylinders crossed and required the physician to reinsert the cylinders.When the physician was inserting the left cylinder it was found that it would no longer maintain its shape or fluid.A tactra penile prosthesis was attempted to replace the cylinders; however, a urethral injury was identified when the tactra appeared through the meatus.All components were explanted and the injury was addressed.The patient is expected to fully recover.

Event Description

It was reported that the patient underwent surgical intervention to implant an inflatable penile prosthesis (ipp).During the procedure, the cylinders crossed and required the physician to reinsert the cylinders.When the physician was inserting the left cylinder it was found that it would no longer maintain its shape or fluid.A tactra penile prosthesis was attempted to replace the cylinders; however, a urethral injury was identified when the tactra appeared through the meatus.All components were explanted and the injury was addressed.The patient is expected to fully recover.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17925740
• MDR Text Key: 325538346
• Report Number: 2124215-2023-56549
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: 08714729979340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0029295958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 70 YR