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

Model Number UNK-P-SPP

Device Problems Break (1069); Material Puncture/Hole (1504); Defective Device (2588)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Urinary Tract Infection (2120); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced rigidity issues with a spectra penile prosthesis (spp).A replacement surgery was performed in which the existing spectra was removed and a new tactra penile prosthesis was implanted.During the procedure there was a noticeable defect in the outer layer of the spectra cylinder.It was indicated there was nothing further to report.No more information available at the moment.Should additional information become available, it will be provided.

Event Description

It was reported that the patient experienced rigidity issues with a spectra penile prosthesis (spp).A replacement surgery was performed in which the existing spectra was removed and a new tactra penile prosthesis was implanted.During the procedure there was a noticeable defect in the outer layer of the spectra cylinder.It was indicated there was nothing further to report.No more information available at the moment.Should additional information become available, it will be provided.Additional information was received.The patient experienced infection, an inflammation reaction and urinary tract infection leading to the procedure.The patient also experienced "breakdown" of penile implant and induration.Product investigation complete.The spp cylinders were visually inspected and functionally tested.One cylinder performed within specifications.One cylinder had a hole in the outer layer that was the result of sharp instrument damage consistent with explant damage exposing the metal segments.This cylinder was functional.Product analysis did not confirm the allegations of patient dissatisfaction or infection.No more information available at the moment.Should pertinent additional information become available, it will be provided.

Manufacturer Narrative

Product investigation complete.The spp cylinders were visually inspected and functionally tested.One cylinder performed within specifications.One cylinder had a hole in the outer layer that was the result of sharp instrument damage consistent with explant damage exposing the metal segments.This cylinder was functional.Product analysis did not confirm the allegations of patient dissatisfaction or infection.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.Supplemental report will be submitted.

• 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
• MDR Report Key: 9102322
• MDR Text Key: 159590653
• Report Number: 2183959-2019-66320
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-SPP
• Device Catalogue Number: UNK-P-SPP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 10/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR