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); Inflammation (1932); Pain (1994)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that the patient went to the hospital one month after the tactra implant surgery due to pain in the surgical site.As a result of the inspection, inflammation and infection were found and the device was removed.Four month after the explant procedure, when the inflammation treatment with antibiotic and anti-inflammatory medicine was completed, a surgery was performed to implant a new tactra.The cause of the inflammation was not detailed by the hospital.No further patient complications were reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this tactra underwent a thorough analysis.The cylinders were visually and microscopically examined.No anomalies were found with the tactra.Based on the information available and analysis results, the product analysis was unable to confirm any device issue that could have caused or contributed to the reported clinical observation of inflammation, pain and infection.

Event Description

It was reported that the patient went to the hospital one month after the tactra implant surgery due to pain in the surgical site.As a result of the inspection, inflammation and infection were found and the device was removed.Four month after the explant procedure, when the inflammation treatment with antibiotic and anti-inflammatory medicine was completed, a surgery was performed to implant a new tactra.The cause of the inflammation was not detailed by the hospital.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: 15191600
• MDR Text Key: 297514478
• Report Number: 2124215-2022-29462
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/09/2022

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: 0027376987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• 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: 58 YR
• Patient Sex: Male