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

Model Number	720054-01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there is a system failure of the spectra penile prosthesis (spp) device and because the "implant deflected." it was further reported the system failure was the patient's "inability to end a sexual intercourse." the patient's penis was deflection to the left side due to the prosthesis.It is planned that the that the revision will be performed on (b)(6) 2019.It was also further reported that the spp was explanted and a new 16 cm ambicor penile prosthesis (app) device was implanted.The outcome of the surgery was successful.The patient is under observation until the implant is activated.
Event or Problem Description
It was reported that there is a system failure of the spectra penile prosthesis (spp) device and because the implant deflected.It was further reported the system failure was the patient's inability to end a sexual intercourse.The patient's penis was deflection to the left side due to the prosthesis.It is planned that the that the revision will be performed on (b)(6) 2019.It was also further reported that the spp was explanted and a new 16cm ambicor penile prosthesis (app) device was implanted.The outcome of the surgery was successful.The patient is under observation until the implant is activated.
Additional Manufacturer Narrative
Malfunction was reported.The spectra 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 tool damage consistent with explant damage.This cylinder was functional.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 bsc.The investigation conclusion code of no problem detected was chosen as the reported device problem could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.If further information is received at a later date, the product investigation will be reopened to address the additional information.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8799182
• Report Number: 2183959-2019-65077
• Device Sequence Number: 335653
• Product Code: FAE
• UDI-Device Identifier: 00878953005201
• UDI-Public: 00878953005201
• Combination Product (Y/N): N
• Initial Reporter Country: GT
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2019

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: 11/12/2020
• Device Model Number: 720054-01
• Device Catalogue Number: 720054-01
• Device Lot Number: 0111592003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR