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 Problem Necrosis (1971)

Event Date 05/08/2021

Event Type  Injury  

Event Description

It was reported the patient underwent a surgical procedure to remove their tactra malleable penile prosthesis approximately two weeks post-implant due to necrosis of the glans.It was noted that the patient is (b)(6) years old and diabetic; they also contracted covid-19 following implant of the tactra.No additional patient complications were reported; the patient was stable following the procedure.

Manufacturer Narrative

Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported necrosis is a known risk associated with penile prosthesis procedures and is noted as such in the instructions for use (ifu).Dhr review: review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the tactra instructions for use (ifu) was reviewed.The patient symptom of necrosis was found to be listed in the ifu.Medical review assessment determined the data reasonably suggest the clinical event is anticipated in nature and severity as per the ifu and hazard analysis (ha).Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported the patient underwent a surgical procedure to remove their tactra malleable penile prosthesis approximately two weeks post-implant due to necrosis of the glans.It was noted that the patient is 62 years old and diabetic; they also contracted covid-19 following implant of the tactra.No additional patient complications were reported; the patient was stable following the 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
• MDR Report Key: 11886179
• MDR Text Key: 252691634
• Report Number: 2124215-2021-14777
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0025827005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention