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

Model Number	720056-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: approximated based on event description, as erosion was identified approximately six months prior replacement surgery.
Event or Problem Description
It was reported that the patient with this inflatable spectra penile prosthesis (spp) experienced erosion in right corpora cavernosa.After approximately six months prior the erosion diagnosis, a surgical procedure was performed, wherein the spp was removed and replaced with a tactra malleable penile prosthesis.It was later reported that vascular disease may have contributed to the erosion.There were no additional patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable spectra penile prosthesis (spp) experienced erosion in the right corpora cavernosa.A surgical procedure was performed, wherein the spp was removed.Approximately six months later, a tactra malleable penile prosthesis was implanted.Additional information was received indicating that vascular disease may have contributed to the erosion.There were no additional patient complications reported.
Additional Manufacturer Narrative
Event date b3: approximated based on event description, as erosion was identified approximately six months prior replacement surgery.This complaint component has not been returned; therefore, no physical or visual analysis of the product could be performed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Due to the lack of product return, the clinical observation of erosion could not be confirmed.

• 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 CORPORATION; 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: 14257098
• Report Number: 2124215-2022-14299
• Device Sequence Number: 20045361
• Product Code: FAE
• UDI-Device Identifier: 00878953005249
• UDI-Public: 00878953005249
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: 08/23/2016
• Device Model Number: 720056-02
• Device Catalogue Number: 720056-02
• Device Lot Number: 730134001
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 04/30/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2011
• 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: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Unknown