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

Model Number 720081-01

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Perforation (2001); Deformity/ Disfigurement (2360)

Event Date 02/04/2021

Event Type  Injury  

Event Description

The patient underwent a surgical procedure to remove and replace this tactra malleable penile prosthesis due to the tips not extending into the glans causing a tilted appearance.A new tactra device was implanted.It was noted that length of the device may have been incorrect in addition to the possibility that a perforation occurred during implant.No additional information was reported.

Manufacturer Narrative

This report is being submitted to provide corrected event information as well as additional information received since the previous report.

Event Description

The patient underwent a surgical procedure to remove and replace this tactra malleable penile prosthesis due to the tips not extending into the glans causing a tilted appearance.A new tactra device was implanted.It was noted that length of the device may have been incorrect in addition to the possibility that a perforation occurred during implant.No additional information was reported.Additional information was received that during the original procedure, only one cylinder was removed and replaced.Approximately two months later, another procedure was performed wherein the other original cylinder was removed and replaced to further address the continued tilted appearance.

Manufacturer Narrative

This report is being submitted to provide additional product information.

Event Description

The patient underwent a surgical procedure to remove and replace this tactra malleable penile prosthesis due to the tips not extending into the glans causing a tilted appearance.A new tactra device was implanted.It was noted that length of the device may have been incorrect in addition to the possibility that a perforation occurred during implant.No additional information was reported.Additional information was received that during the original procedure, only one cylinder was removed and replaced.Approximately two months later, another procedure was performed wherein the other original cylinder was removed and replaced to further address the continued tilted appearance.

Manufacturer Narrative

Investigation summary: with all the available information, boston scientific concludes as no further information regarding this event is expected, our investigation is complete.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: a single tactra cylinder was returned for analysis.The cylinder was visually and microscopically inspected.The rear tip of the cylinder was identified to be trimmed to approximately 154mm with the use of a sharp instrument.Based on the nature of the observed damage, it was determined that it likely occurred during the implant procedure.Labeling review: perforation is listed as a potential adverse event in the instructions for use (ifu).Review of labeling determined the complaint situation was listed in the manual.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 unintended use error caused or contributed to event.

Event Description

The patient underwent a surgical procedure to remove and replace this tactra malleable penile prosthesis due to the tips not extending into the glans causing a tilted appearance.A new tactra device was implanted.It was noted that length of the device may have been incorrect in addition to the possibility that a perforation occurred during implant.No additional information was reported.Additional information was received that during the original procedure, only one cylinder was removed and replaced.Approximately two months later, another procedure was performed wherein the other original cylinder was removed and replaced to further address the continued tilted appearance.

• 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: 11358518
• MDR Text Key: 232829682
• Report Number: 2183959-2021-00603
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/11/2021

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: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0024047833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 04/15/2021; 04/16/2021; 06/10/2021
• Supplement Dates FDA Received: 04/15/2021; 05/04/2021; 06/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR