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

Model Number	720082-01
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this tactra device was not used and instead, an ambicor penile prosthesis (app) was used since it was a better fit for the patient.Also, a proximal perforation was noted during surgery.The rear tips were sutured to the corpora to let the patient heal since this perforation was unknown until the time of the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this tactra underwent a thorough analysis.The cylinders were visually and microscopically examined.No anomalies were found with the cylinders.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Common Device Name: 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16087615
• Report Number: 2124215-2022-55696
• Device Sequence Number: 15113346
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: 08714729979364
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K183619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/25/2026
• Device Model Number: 720082-01
• Device Catalogue Number: 720082-01
• Device Lot Number: 0027323375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: Black Or African American