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

Model Number 720081-01

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2021

Event Type  Injury  

Event Description

It was reported that the patient implanted with this tactra malleable penile prosthesis experienced a left lateral curvature of their penis preventing intercourse.The patient also reported inability to position/conceal the device as desired causing embarrassment in some situations.Additional information was later received indicating a surgical procedure was performed wherein this device was explanted and replaced with a new spectra penile prosthesis (spp).No patient complications were reported.

Event Description

It was reported that the patient implanted with this tactra malleable penile prosthesis experienced a left lateral curvature of their penis preventing intercourse.The patient also reported inability to position/conceal the device as desired causing embarrassment in some situations.Additional information was later received indicating a surgical procedure was performed wherein this device was explanted and replaced with a new spectra penile prosthesis (spp).No patient complications were reported.

Manufacturer Narrative

Investigation summary: based on the information available, the cause that contributed to the reported lateral curvature and inability to position/conceal the product cannot be established as the product is not available for analysis.Device history record (dhr): review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: a review of the tactra instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that the patient implanted with this tactra malleable penile prosthesis experienced a left lateral curvature of their penis preventing intercourse.The patient also reported inability to position/conceal the device as desired causing embarrassment in some situations.Additional information was later received indicating a surgical procedure was performed wherein this device was explanted and replaced with a new spectra penile prosthesis (spp).No patient complications were reported.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes the reported event is a known inherent risk of the tactra malleable penile prosthesis.No product deficiencies were identified during the course of this investigation.This report will be updated should additional information be provided.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Device technical analysis: the complaint device was returned and thoroughly analyzed.Visual and microscopic inspection did not identify any damage or abnormality.Both cylinders were trimmed at approximately 18 cm.Analysis was unable to confirm the reported clinical observations.Labeling review: review of the tactra hazard analysis determined the complaint situation is a known potential adverse event.There was no indication in the complaint that the product was not used in accordance to the labeling.The manual was unlikely to be the cause of the reported complaint.Investigation conclusion: no further actions are considered necessary and the complaint investigation conclusion code is known inherent risk of device.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11800997
• MDR Text Key: 249949509
• Report Number: 2124215-2021-13465
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0025475993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR