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

Model Number 720082-01

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2020

Event Type  Injury  

Event Description

It was reported that this patient underwent a surgical procedure due to their tactra malleable penile prosthesis exhibiting penile asymmetry.No information was provided regarding the status of the implanted device.The patient was reported to be well following the procedure.Additional information was received indicating the physician believed the asymmetry was a result of incorrect device size for the patient.One of the cylinders was removed.No further information could be obtained.

Event Description

It was reported that this patient underwent a surgical procedure due to their tactra malleable penile prosthesis exhibiting penile asymmetry.No information was provided regarding the status of the implanted device.The patient was reported to be well following the procedure.Additional information was received indicating the physician believed the asymmetry was a result of incorrect device size for the patient.One of the cylinders was removed.No further information could be obtained.Further information was later provided indicating another procedure was performed wherein the remaining 13mm cylinder was removed.A new 11mm tactra device was then implanted.No patient complications were reported.

Manufacturer Narrative

Updated - b5: describe event or problem, h6: evaluation method codes, h6: evaluation result codes, h6: evaluation conclusion codes.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10740753
• MDR Text Key: 213209497
• Report Number: 2183959-2020-05052
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979364
• UDI-Public: 08714729979364
• Combination Product (y/n): N
• PMA/PMN Number: K183619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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 Expiration Date: 05/13/2020
• Device Model Number: 720082-01
• Device Catalogue Number: 720082-01
• Device Lot Number: 0023786969
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR