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

Model Number 720081-01

Device Problem Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/04/2023

Event Type  Injury  

Event Description

It was reported that the patient presented significant displacement of the prosthesis after the first sexual intercourse, after surgery.Magnetic resonance imaging was performed and a fracture of the tunica albugin of the left corpus cavernosa, with dorsal displacement of the implant was noted.There were no additional patient complications.No further information was provided.

Event Description

It was reported that the patient presented significant displacement of the prosthesis after the first sexual intercourse, after surgery.Magnetic resonance imaging was performed and a fracture of the tunica albugin of the left corpus cavernosa, with dorsal displacement of the implant was noted.There were no additional patient complications.No further information was provided.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.The reported patient symptom is a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient presented significant displacement of the prosthesis after the first sexual intercourse, after surgery.Magnetic resonance imaging was performed and a fracture of the tunica albugin of the left corpus cavernosa, with dorsal displacement of the implant was noted.There were no additional patient complications.No further information was provided.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17719680
• MDR Text Key: 323073256
• Report Number: 2124215-2023-49030
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/23/2023

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: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0040007185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/08/2023; 09/29/2023
• Supplement Dates FDA Received: 09/15/2023; 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Male