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

Model Number UNK-P-TACTRA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  Injury  

Event Description

It was reported that this patient underwent a surgical procedure to replace a previous unknown boston scientific device with a tactra malleable penile prosthesis.The reason for the procedure was not specified.No patient complications were reported.Despite efforts, no additional information could be obtained.

Manufacturer Narrative

B5 updated.

Event Description

It was reported that that this patient underwent a surgical procedure to replace a previous unknown boston scientific device with a tactra malleable penile prosthesis.The reason for the procedure was not specified.No patient complications were reported.Additional information was received clarifying the explanted device was removed during a separate procedure on an unknown date.It was noted that the patient desired a new penile prosthesis in addition to an artificial urinary sphincter (aus) which was also implanted.The patient was reported to be well following the procedure and was satisfied with both devices.The explanted device will not be returned.

• 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: 10388588
• MDR Text Key: 202357376
• Report Number: 2183959-2020-03445
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-TACTRA
• Device Catalogue Number: UNK-P-TACTRA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR