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

Model Number 720074-02

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 305411956
• Report Number: 2124215-2022-51454
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 11/25/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male