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

Model Number 720080-01

Device Problem Difficult to Insert (1316)

Patient Problem Perforation (2001)

Event Date 07/13/2023

Event Type  Injury  

Event Description

It was reported that the physician was trying to implant a tactra malleable device.During the procedure, the doctor experienced difficulty to implant the device.While the physician was trying to dilate the fibrotic tissue the urethra was perforated, it was surgical repaired, but it was decided to abort the procedure.The doctor noted at the end of the case that he felt it would be very difficult if not impossible to re attempt a revision surgery.No further procedures are scheduled for this patient.

Event Description

It was reported that the patient had an inflatable penile prosthesis (ipp) implanted in 2020.At some point, the patient developed an infection, and the device was removed.On a follow up procedure, the physician was trying to implant a tactra malleable device.During the procedure, it was noticed there was an excessive fibrosis/scarring and the doctor experienced difficulty to implant the device.While the physician was trying to dilate the fibrotic tissue the urethra was perforated, it was surgical repaired, but it was decided to abort the procedure.The doctor noted at the end of the case that he felt it would be very difficult if not impossible to re attempt a revision surgery.No further procedures are scheduled for this patient.

Manufacturer Narrative

Upon receipt of this tactra at our quality assurance laboratory, the returned components underwent a thorough analysis.The cylinders were visually examined and microscopically tested.Analysis of the device identified the cylinders performed within specifications and no anomalies were found.The reported patient harm of perforation is a known risk associated with inflatable penile prosthesis (ipp) and is noted as such in the device instructions for use.

• 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: 17444568
• MDR Text Key: 320243907
• Report Number: 2124215-2023-40889
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979340
• UDI-Public: 08714729979340
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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: Health Professional
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0029260475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male