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 Problems Wound Dehiscence (1154); Unspecified Infection (1930); Necrosis (1971); Urinary Tract Infection (2120)

Event Date 05/17/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced an urinary tract infection after the implant surgery of this tactra malleable penile prothesis.The infection led to scrotal pus, necrotic tissue and an open wound.Subsequently, the patient underwent a surgical procedure during which the physician performed a four-part washout and tissue debridement; in addition, the existing tactra was removed and replaced with a new malleable device.Upon explant, no device issues were identified.There were no further patient complications reported.

Manufacturer Narrative

The device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The device instructions for use (ifu) was reviewed.The patient symptoms of infection, necrosis and open wound were found to be listed in the ifu.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient experienced an urinary tract infection after the implant surgery of this tactra malleable penile prothesis.The infection led to scrotal pus, necrotic tissue and an open wound.Subsequently, the patient underwent a surgical procedure during which the physician performed a four-part washout and tissue debridement; in addition, the existing tactra was removed and replaced with a new malleable device.Upon explant, no device issues were identified.There were no further patient complications reported.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17076301
• MDR Text Key: 316657841
• Report Number: 2124215-2023-28625
• Device Sequence Number: 1
• Product Code: FAE
• 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: 07/05/2023

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: 0029584840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male