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

Model Number 720080-01

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

Patient Problem Necrosis (1971)

Event Date 12/03/2019

Event Type  Injury  

Event Description

It was reported that the patient implanted with this tactra malleable penile prosthesis experienced necrosis of the glans penis.The patient is scheduled to undergo a surgical procedure to remove the necrotic tissue.No additional adverse patient effects were reported.Additional information was received indicating approximately 20 percent of the glans penis was necrosed and will be removed on an unspecified date.The physician intends to leave the malleable prosthesis implanted.

Event Description

It was reported that the patient implanted with this tactra malleable penile prosthesis experienced necrosis of the glans penis.The patient is scheduled to undergo a surgical procedure to remove the necrotic tissue.No additional adverse patient effects were reported.Additional information was received indicating approximately 20 percent of the glans penis was necrosed and will be removed on an unspecified date.The physician intends to leave the malleable prosthesis implanted.Further information was provided that the cause of necrosis was not determined nor did the patient experience infection at the site.However, it was noted the patient had a history of vascular problems with comorbidities.The revision procedure was performed and the patient was reported to be recovering well.

Manufacturer Narrative

B5 updated with additional information.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9729065
• MDR Text Key: 180584301
• Report Number: 2183959-2020-00752
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: 08714729979340
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0024519449
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/19/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention