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

Model Number	720074-02
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Perforation (2001)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced right cylinder extrusion through the urethra with a spectra penile prosthesis (spp).It was indicated that there was no penile trauma or sexual intercourse with exaggerated force leading to the extrusion.
Event or Problem Description
It was reported that the patient experienced left cylinder extrusion through the urethra with a spectra penile prosthesis (spp).A surgical procedure was performed in which the cylinder was removed.It was indicated that the right cylinder remained implanted as the erection was still satisfactory.A month later, the remaining rod extruded through the urethra.It was indicated that there was no penile trauma or sexual intercourse with exaggerated force leading to the extrusion.No further information was provided.
Additional Manufacturer Narrative
There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12833026
• Report Number: 2124215-2021-35915
• Device Sequence Number: 6221876
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 11/08/2021
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 0155875002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male