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 Abscess (1690); Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Perforation (2001)

Event Date 04/01/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced pain due to infection after initial tactra malleable penile prosthesis surgical implant.The physician believed that the infection was due to the patients history of smoking and treated the patient with antibiotics.The infection continued to progress, and it was determined that surgical intervention would be required.During the procedure, the physician identified a corporal perforation, pus, hematoma, and an abscess.The wounds were evacuated and the tactra malleable penile prosthesis was explanted.No further patient complications were reported.

Event Description

It was reported that the patient experienced pain due to infection after initial tactra malleable penile prosthesis surgical implant.The physician believed that the infection was due to the patients history of smoking and treated the patient with antibiotics.The infection continued to progress, and it was determined that surgical intervention would be required.During the procedure, the physician identified a corporal perforation, pus, hematoma, and an abscess.The wounds were evacuated and the tactra malleable penile prosthesis was explanted.No further patient complications were reported.

Manufacturer Narrative

Correction made to a1 patient identifier, a2 date of birth, a2 age at time of event, a2 unit of measure for years, and a3 sex.

Event Description

It was reported that the patient experienced pain due to infection after initial tactra malleable penile prosthesis surgical implant.The physician believed that the infection was due to the patients history of smoking and treated the patient with antibiotics.The infection continued to progress, and it was determined that surgical intervention would be required.During the procedure, the physician identified a corporal perforation, pus, hematoma, and an abscess.The wounds were evacuated and the tactra malleable penile prosthesis was explanted.No further patient complications were reported.

Manufacturer Narrative

Based on the information available, product analysis of the tactra malleable penile prosthesis did not confirm a product malfunction.The cylinders were visually and microscopically inspected with observations that the cylinders were trimmed, but with no visual damages.Review of the manufacturing documentation did not find any evidence that the device failed to meet product specifications prior to shipment.A medical review assessment was performed reasonably suggesting that the clinical events that occurred are anticipated in nature and severity per the instructions for use and hazard analysis.There was no evidence of the device being handled improperly.The allegations of pain, infection, perforation, and hematoma are included in the product labelling and hazard analysis; therefore, these events are known inherent risks with the tactra malleable penile prosthesis.

• 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 ; 4089353452
• MDR Report Key: 14258138
• MDR Text Key: 290473943
• Report Number: 2124215-2022-14302
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 07/14/2022

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: 0027166027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/02/2022
• Supplement Dates Manufacturer Received: 05/25/2022; 06/27/2022
• Supplement Dates FDA Received: 06/14/2022; 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Male