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

Model Number UNK-P-TACTRA

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Discomfort (2330)

Event Date 12/20/2023

Event Type  Injury  

Event Description

It was reported that the patient with this tactra malleable penile prosthesis experienced pain and discomfort in the perineum and anus region.The patient stated that he is able to palpate the proximal tip of the rod in the anus and that he can also feel it when he is driving and seated; due to that, he cannot bend his penis, resulting in a constant erection.The urologist evaluated him and confirmed that the tactra is not in the correct place anymore and, therefore, as surgical procedure is needed.A cylinder crossover and extrusion are suspected.No additional information was 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 device as indicated 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.

Event Description

It was reported that the patient with this tactra malleable penile prosthesis experienced pain and discomfort in the perineum and anus region.The patient stated that he is able to palpate the proximal tip of the rod in the anus and that he can also feel it when he is driving and seated; due to that, he cannot bend his penis, resulting in a constant erection.The urologist evaluated him and confirmed that the tactra is not in the correct place anymore and, therefore, as surgical procedure is needed.A cylinder crossover and extrusion are suspected.No additional information was 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 device as indicated 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.

Event Description

It was reported that the patient with this tactra malleable penile prosthesis experienced pain and discomfort in the perineum and anus region.The patient stated that he was able to palpate the proximal tip of the rod in the anus and that he could also feel it when he was driving and seated; due to that, he could not bend his penis, resulting in a constant erection.The urologist evaluated him and confirmed that the tactra was not in the correct place anymore and, therefore, as surgical procedure was needed.A cylinder crossover and extrusion were suspected.Two months later, a replacement surgery was performed, during which the malleable device was removed, and a new inflatable penile prosthesis was implanted.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: 18455513
• MDR Text Key: 332204137
• Report Number: 2124215-2024-00280
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

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: UNK-P-TACTRA
• Device Catalogue Number: UNK-P-TACTRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/30/2024; 02/23/2024
• Supplement Dates FDA Received: 02/12/2024; 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male