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

Model Number 720080-01

Device Problem Defective Device (2588)

Patient Problem Discomfort (2330)

Event Date 12/05/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced difficulty penetrating their partner and was dissatisfied with the tactra device.Additionally, the patient experienced discomfort as laxity of the glans was observed; a minor procedure to correct the issue was performed.The physician recommended to replace the device with an inflatable penile prosthesis (ipp) and scheduled a revision.No further patient complications were reported.

Manufacturer Narrative

There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom of discomfort is a known risk associated with implants of these devices as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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 difficulty penetrating their partner and was dissatisfied with the tactra device.Additionally, the patient experienced discomfort as laxity of the glans was observed; a minor procedure to correct the issue was performed.The physician recommended to replace the device with an inflatable penile prosthesis (ipp) and scheduled a revision.No further patient complications were 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16026390
• MDR Text Key: 305926709
• Report Number: 2124215-2022-54050
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: 08714729979340
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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
• Device Lot Number: 0028526241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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): Hospitalization; Required Intervention
• Patient Sex: Male