MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

Catalog Number 72404323

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2017

Event Type  Injury  

Event Description

It was reported the during the implant procedure, the patient experienced an issue with a rear tip extender for his spectra penile prosthesis cylinder.The surgeon placed a "3.0 cm [rear tip extender and it] got stuck and came off." the physician indicated it could not be found so he implanted a different 3.0 cm rear tip extender.The initial rear tip extender was not located.No further patient complications were reported in relation to this event.

Manufacturer Narrative

Describe event or problem.

Event Description

It was later reported the physician attempted to "remove/reposition one penile cylinder (and the rear tip extender) detached in the process." it was not located and is noted as remaining in the patient.A different rear tip extender was used in the procedure.No further patient complications were reported in relation to this event.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 7070765
• MDR Text Key: 93327968
• Report Number: 2183959-2017-00112
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005393
• UDI-Public: 00878953005393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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: 08/15/2022
• Device Catalogue Number: 72404323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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): Required Intervention
• Patient Age: 56 YR