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

Model Number 720080-01

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

Patient Problems Depression (2361); Sexual Dysfunction (4510)

Event Date 06/08/2023

Event Type  Injury  

Event Description

It was reported that the patient experienced glans flaccidity and an inability to maintain sexual intercourse due to the tactra cylinders not being the adequate size.The patient developed a severe depression as a result of the situation.A surgical procedure was requested to address the concerns; however, it has not been scheduled yet.No additional information was reported.

Manufacturer Narrative

The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.A review of the device instructions for use (ifu) was completed, and it indicates: patients should be counseled in order to have a realistic expectation of the physical, psychological, and functional outcome of the implantation of a rigid penile prosthesis.Implantation of a penile prosthesis may result in penile shortening, curvature, or scarring.The prosthetic erection may differ from the original, natural erection in that it may be shorter, less firm, have less girth, and reduced sensations.Unsuccessful outcomes have been reported due to improper surgical technique, anatomical misplacement of the device, or improper sizing of cylinders.The reported patient symptom of sexual dysfunction is a known risk associated with tactra procedures and is noted as such in the device risk documentation.While depression is not listed, device inadequate for sexual activity, inappropriate cylinder size selection was noted as a potential adverse event.The information reasonably suggests that the feeling of depression may occur as a result of patient dissatisfaction or inability to use the tactra device as intended.The implantation of a penile prosthesis will not provide rigidity to the glans and may result in a floppy glans and lack of rigidity of the corpus spongiosum.Penile flaccidity will be less than prior to implantation.There is no evidence that the device was used or handled improperly.Based on the information available, a conclusion code of unintended use error caused or contributed to event was assigned to this investigation.

Event Description

It was reported that the patient experienced glans flaccidity and an inability to maintain sexual intercourse due to the tactra cylinders not being the adequate size.The patient developed a severe depression as a result of the situation.A surgical procedure was requested to address the concerns; however, it has not been scheduled yet.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17639966
• MDR Text Key: 322134567
• Report Number: 2124215-2023-46432
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/21/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: 720080-01
• Device Catalogue Number: 720080-01
• Device Lot Number: 0028030109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR