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

Catalog Number	72404323
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Describe event or problem.
Event or Problem 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
• Common Device Name: PROSTHESIS, PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 7070765
• Report Number: 2183959-2017-00112
• Device Sequence Number: 1571645
• Product Code: FAE
• UDI-Device Identifier: 00878953005393
• UDI-Public: 00878953005393
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/15/2022
• Device Catalogue Number: 72404323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR