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

Model Number 720081-01

Device Problem Mechanical Problem (1384)

Patient Problems Emotional Changes (1831); Discomfort (2330)

Event Date 08/03/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort and emotional stress due to their tactra malleable penile prosthesis buckling/bowing resulting in concealment problems and inability to use the device.It was further noted the patient did not believe the device had a natural feeling.The physician attempted to straighten the device in office but was unsuccessful.A surgical procedure was performed wherein the tactra prosthesis was explanted and replaced with a new inflatable penile prosthesis (ipp).No patient complications were reported.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported cylinder buckling, concealment issues, discomfort, and dissatisfaction cannot be established as the product is not available for analysis.Device history record (dhr): a dhr and ship history review cannot be performed as the lot# number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the tactra instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient experienced discomfort and emotional stress due to their tactra malleable penile prosthesis buckling/bowing resulting in concealment problems and inability to use the device.It was further noted the patient did not believe the device had a natural feeling.The physician attempted to straighten the device in office but was unsuccessful.A surgical procedure was performed wherein the tactra prosthesis was explanted and replaced with a new inflatable penile prosthesis (ipp).No 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
• MDR Report Key: 12325625
• MDR Text Key: 266700985
• Report Number: 2124215-2021-24668
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR