MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number 720074-01

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Depression (2361)

Event Date 11/26/2019

Event Type  malfunction  

Event Description

It was reported that the patient was submitted spectra prosthesis implantation on (b)(6) 2019.During dilation, we reached the 14-15 caliber but the most caliber prosthesis available was 12 caliber.The prosthesis is placed in situ but the patient is quite disappointed and dissatisfied as it is complained that the prosthesis does not provide the stiffness.Necessary for satisfactory penetration and relationship.The patient reports shame and post-surgical depression due to the ineffectiveness of the procedure.Additional information received indicated a 14 mm cylinder wasn't available as it was not standard practice to have that specific size in stock.Intervention or a revision surgery has not been scheduled yet.The device function looked god at the time of the implant, but the patient complained that the penis without sustaining and the penis double of the relationship time.During x-ray, it was noted that the device needs to be a 14 mm device because it was broken within the cave's body.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 9546773
• MDR Text Key: 175424433
• Report Number: 2183959-2019-68465
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2020

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: 02/27/2023
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 1000064551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR