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

Model Number 720080-01

Device Problem Malposition of Device (2616)

Patient Problem Erosion (1750)

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that this malleable penile prosthesis was removed as one cylinder was malpositioned and pressing on the glans, thinning out the distal tissue resulting in erosion.A new inflatable penile prosthesis was implanted.No patient complications were reported.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.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.This investigation also assigned a most probable conclusion code of unintended use error caused or contributed to event.This conclusion was selected because the reason for malposition of device, erosion was determined to be inadvertent/unintentional interaction.Furthermore, according with the information in the event description, the device was on good condition when the package was open.The evidence from the product record review did not identify a potential product quality issue or new patient harm.Therefore, it can be concluded that inadvertent/unintentional interaction was the most probable cause of the complaint/event.

Event Description

It was reported that this malleable penile prosthesis was removed as one cylinder was malpositioned and pressing on the glans, thinning out the distal tissue resulting in erosion.A new inflatable penile prosthesis was implanted.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 ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18563463
• MDR Text Key: 333470974
• Report Number: 2124215-2024-03276
• Device Sequence Number: 1
• Product Code: FAE
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 57 YR
• Patient Sex: Male