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

Model Number 720081-01

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Insufficient Information (4580)

Event Date 04/11/2022

Event Type  Injury  

Event Description

During the implant of this tactra penile prosthesis, the cylinders were implanted and an injury to the urethra was observed.The cylinders were removed and the physician performed an urethrorrhaphy.When attempting to re-implant the cylinders, inflammation of the corpora cavernosa and the general area was observed; therefore, the physician decided to abort the implantation and perform closure.There were no additional patient complications reported.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported injury to the urethra and other patient observations can't be confirmed.Device history record (dhr): the device history record (dhr) confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: a labeling review was performed and according to the tactra instructions for use and hazard documentation, inflammation and injury are documented as risks.Also there is no evidence that the device was used or handled improperly.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

During an implant procedure of this tactra penile prosthesis, the cylinders were implanted and an injury to the urethra was observed.The cylinders were removed and the physician performed an urethrorrhaphy.When trying to re-implant the cylinders, inflammation of the corpora cavernosa and the surrounding area was observed and, therefore, it was decided to abort the procedure and close the incision.There were no additional patient complications 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 14215217
• MDR Text Key: 290144843
• Report Number: 2124215-2022-13481
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 05/05/2022

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: 0028756678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 05/05/2022
• Supplement Dates FDA Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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
• Treatment: DILATORS 720117-01/1100021000; DILATORS 720117-01/1100021000
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male