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

Model Number 720081-01

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported perforation is a known risk associated with malleable penile prosthesis implant procedures and is noted as such in the tactra instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot# number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the tactra instructions for use (ifu) was reviewed.Perforation was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.

Event Description

It was reported that the patient experienced both proximal and distal perforations during a procedure to implant a tactra malleable penile prosthesis.Initial dilation was completed and the physician attempted to insert a 13mm device but was not able to fit it in the corpora.The physician began downsizing the implant until the nitinol core became exposed and elected to implant an alternate 11mm device instead.When sizing the 11mm implant, the cylinders were trimmed until the nitinol core was exposed once more.The physician continued to trim the cylinders to a length of 12cm with a 1cm rear tip extender and was able to successfully place the implant.Per the physician, it was during the process of attempted implant and eventual insertion of the implants that the perforations occurred due to stiffness of the cylinders.It was noted that no additional intervention was required to treat the perforations.No additional 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 11738705
• MDR Text Key: 247785441
• Report Number: 2124215-2021-10749
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR