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

Model Number 720080-01

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  Injury  

Event Description

It was reported that the patient with this tactra penile prosthesis presented with cross over of the implant.A ct scan determined that the device had crossed over towards the proximal end.The physician did not suspect the cross over was due to the device, but rather the sub coronal approach not providing easy proximal dilation.The device was explanted, and a new tactra was implanted.There were no 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
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18933178
• MDR Text Key: 338025870
• Report Number: 2124215-2024-16266
• 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: Other,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male