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

Model Number	720074-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Erosion (1750); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient with a spectra penile prosthesis requires surgical intervention for unspecified reasons.There has been no surgical intervention or patient complications reported.
Additional Manufacturer Narrative
Additional information provided to update a2 age at time of event, b5 describe event or problem d6b explant date, g1 mfr contact first and last name, mfr contact email, h6 patient code, evaluation conclusion code, h10 additional mfr.Narrative there was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent surgical intervention to explant the spectra penile prosthesis due to erosion of the corpora.The corpora was fixed and a tactra penile prosthesis was implanted.There were no further patient complications.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15973663
• Report Number: 2124215-2022-51454
• Device Sequence Number: 5784808
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• 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): 12/12/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/08/2024
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 1000229834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 11/25/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2019
• 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: 73 YR
• Patient Sex: Male