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

Model Number 720081-01

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

Patient Problems Unspecified Infection (1930); Necrosis (1971); Pain (1994); Insufficient Information (4580)

Event Date 02/02/2022

Event Type  Injury  

Event Description

It was reported that the patient with this tactra malleable penile prosthesis developed infection; which necessitated the explant of the right cylinder and a washout to the affected area.Approximately two months after the procedure, the patient presented persistent eschar, which ultimately led to an eschar excision.In addition, the patient experienced peyronies disease and pain; the penile curvature was corrected and the pain ceased after the last intervention.A surgical procedure to re-implant the right cylinder is to be scheduled.

Manufacturer Narrative

This complaint component has not been returned; therefore, no physical or visual analysis of the product could be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Due to the lack of product return, the clinical observations of necrosis, pain, infection, and peyronies disease could not be confirmed.However, the product labeling lists infection, necrosis and pain as potential adverse events associated with implant of this device.Additionally, there is no objective evidence that the user did not properly handle or use the device according to the tactra instructions for use.The reported events also do not contain an allegation against the labeling.

Event Description

It was reported that the patient with this tactra malleable penile prosthesis developed infection; which necessitated the explant of the right cylinder and a washout to the affected area.Approximately two months after the procedure, the patient presented persistent eschar, which ultimately led to an eschar excision.In addition, the patient experienced peyronies disease and pain; the penile curvature was corrected and the pain ceased after the last intervention.A surgical procedure to re-implant the right cylinder was performed, and no patient complications were reported in relation to this procedure.

• 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: 14877414
• MDR Text Key: 295068314
• Report Number: 2124215-2022-23677
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• 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
• Report Date: 07/28/2022

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: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0027866716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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 Age: 46 YR
• Patient Sex: Male