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

Model Number	720056-03
Medical Device Problem Codes	Mechanical Problem (1384); Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient, enrolled in it matters clinical study with this spectra penile prosthesis, suspects that their penis is shorter than it was prior to implant six months ago.The patient is unable to use the device as often as they liked.The physician believed that there are no device issues, and the outcome is based on the subjective opinion of the patient.At the twelve-month follow-up, the patient reported that the device moves into the body and is too flexible when attempting sexual intercourse.The movement into the body shortens the length of the penis and the patient is unable to use the device.The physician later suspected the device was not working and discovered the cylinders were too short and lacked rigidity.The physician replaced the device.There were no additional patient complications reported.
Additional Manufacturer Narrative
Updated h6 evaluation conclusion code.
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis suspects that their penis is shorter than it was prior to implant six months ago.The patient is unable to use the device as often as they liked.The physician believed that there are no device issues and the outcome is based on the subjective opinion of the patient.At the twelve-month follow-up, the patient reported that the device moves into the body and is too flexible when attempting sexual intercourse.The movement into the body shortens the length of the penis and the patient is unable to use the device.The physician later suspected the device was not working and discovered the cylinders were too short and lacked rigidity.The physician replaced the device.There were no additional patient complications reported.

• 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: 20406480
• Report Number: 2124215-2024-62443
• Device Sequence Number: 3351445
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 03/18/2025
• Device Model Number: 720056-03
• Device Catalogue Number: 720056-03
• Device Lot Number: 1000415854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 03/19/2020
• 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: 81 YR
• Patient Sex: Male