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

Model Number 720081-01

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Urinary Frequency (2275); Discomfort (2330)

Event Date 10/04/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort and pain because the length of the implanted tactra penile prosthesis was too large.The patient received unspecified medication and was scheduled for a revision surgery.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

Event Description

It was reported that the patient experienced worsening of urinary frequency after the implant surgery of the implanted tactra penile prosthesis.Thirty-six days after the onset procedure, the patient experienced discomfort and pain because the length of the implanted tactra penile prosthesis was too large.The patient received unspecified medication and was scheduled for a revision surgery.The patient underwent surgery fifty-one days after the implant procedure to replace the device with a smaller size implant.There were no further patient complications reported.

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.

Event Description

It was reported that the patient experienced worsening of urinary frequency after the implant surgery of the implanted tactra penile prosthesis.Thirty-six days after the onset procedure, the patient experienced discomfort and pain because the length of the implanted tactra penile prosthesis was too large.The patient received unspecified medication and was scheduled for a revision surgery.The patient underwent surgery fifty-one days after the implant procedure to replace the device with a smaller size implant.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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18075694
• MDR Text Key: 327473872
• Report Number: 2124215-2023-62007
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0040006889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/07/2023; 12/11/2023
• Supplement Dates FDA Received: 11/27/2023; 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: White