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

Model Number 720081-01

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190); Migration (4003)

Patient Problems Discomfort (2330); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  Injury  

Event Description

It was reported that this tactra penile prosthesis was removed due to unspecified reasons.A new tactra penile prosthesis was implanted.No patient complications were reported.

Event Description

It was reported that this tactra penile prosthesis was removed as the corpus cavernosum had atrophied to the extent that a larger implant had to be inserted.The patient was not able to use the implant properly because it moved slightly and caused uncomfortable marks.A new tactra penile prosthesis was implanted.No patient complications were reported.

Manufacturer Narrative

Corrected data: g1 manufacturing site upon receipt of this tactra penile prosthesis at our quality assurance laboratory, the returned components underwent a thorough analysis.The tactra cylinders were visually inspected.The tactra cylinders were trimmed down to approximately 19.5 cm.Based on the information available and analysis results, the reported device issues were unable to be confirmed and the cause was not established.The analysis was also unable to confirm the reported clinical observations of atrophy and discomfort.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the corpus cavernosum of the patient with this tactra malleable penile prosthesis had atrophied to the extent that a larger implant had to be inserted.The patient was not able to use the implant properly because it moved slightly and caused uncomforatable marks.The device was explanted and replaced with another tactra.No patient complications were reported.

• 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 MA ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17552165
• MDR Text Key: 321219630
• Report Number: 2124215-2023-43651
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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: 11/01/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0025479931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: Not provided; 10/11/2023
• Supplement Dates FDA Received: 09/12/2023; 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Male