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

Model Number UNK-P-TACTRA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); Urethral Stenosis/Stricture (4501)

Event Date 01/17/2023

Event Type  Injury  

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 (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, two days post-implant of a tactra malleable prosthesis, the patient experienced urinary retention.A foley catheter was subsequently placed and removed a week later.No further information was provided.

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 (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, two days post-implant of a tactra malleable prosthesis, the patient experienced urinary retention.A foley catheter was subsequently placed and removed a week later.No further information was provided.Twenty days post-implant the issue has been resolved.

Event Description

It was reported that, two days post-implant of a tactra malleable prosthesis, the patient experienced urinary retention.A foley catheter was subsequently placed and removed a week later.Twenty days post-implant the issue was resolved.Additionally, about a year later, the patient presented with split stream of urine, which has not been resolved yet.There were no additional 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 (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.The following fields were updated: b5: outcomes attrib to adv event, h6: patient codes.

• 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 MA ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16407474
• MDR Text Key: 309870003
• Report Number: 2124215-2023-07371
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2024

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?: No
• 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?: Yes
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/21/2023
• Supplement Dates Manufacturer Received: 03/10/2023; 01/23/2024
• Supplement Dates FDA Received: 03/24/2023; 02/06/2024
• 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): Other