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 Problem Deformity/ Disfigurement (2360)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

As the complaint component was not returned for analysis, no product analysis could be performed.The reported allegations could not be confirmed.If the complaint component is returned at a later date then the product investigation can be re-opened to perform the analysis.A review of the tactra hazard analysis was completed.Device too long is included as a hazard and therapeutic response, altered is included as a harm, although the appropriate hazardous situation could not be identified with the limited information provided.Based on this review, this complaint does not represent a new or unanticipated event.A labeling review was performed and according to the dfu, implantation of a penile prosthesis may result in penile shortening, curvature, or scarring.Is included in the warnings section.Also there is no evidence that the device was used or handled improperly.A review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.

Event Description

It was reported that following implant, the patient implanted with this tactra malleable penile prosthesis presented with curvature of the penis.The physician determined the device was oversized.A surgical procedure was performed wherein the device was removed and reinserted without the need for a new device.No additional patient complications were reported.Additional information was received specifying the curvature was observed mid-shaft of the penis due to the device length being too long for the patient.The device was removed, a portion trimmed from the length, and then reinserted.

• Brand Name: TACTRA MALLEABLE PENILE PROTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 10379855
• MDR Text Key: 202049520
• Report Number: 2183959-2020-03299
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 08714729979357
• UDI-Public: 08714729979357
• 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: 08/07/2020

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 Model Number: 720081-01
• Device Catalogue Number: 720081-01
• Device Lot Number: 0024903568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR