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

Model Number UNK-P-TACTRA

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976); Noise, Audible (3273)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 06/08/2021

Event Type  Injury  

Event Description

It was reported the patient underwent a surgical procedure to remove this tactra malleable penile prosthesis due to the implant buckling resulting in droopy glans.The physician suspected the device was oversized at implant.The existing tactra was explanted and replaced with a new inflatable penile prosthesis (ipp).Upon removal, it was noted the prosthesis was twisted at the base of the nitinol core and would click.There were no patient complications.

Event Description

It was reported the patient underwent a surgical procedure to remove this tactra malleable penile prosthesis due to the implant buckling resulting in droopy glans.The physician suspected the device was oversized at implant.The existing tactra was explanted and replaced with a new inflatable penile prosthesis (ipp).Upon removal, it was noted the prosthesis was twisted at the base of the nitinol core and would click.There were no patient complications.

• 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: 11985064
• MDR Text Key: 255777121
• Report Number: 2124215-2021-16440
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-TACTRA
• Device Catalogue Number: UNK-P-TACTRA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/11/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR