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

Model Number 720056-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 10/02/2023

Event Type  Injury  

Event Description

It was reported that a surgical procedure was performed to remove this malleable penile prosthesis due to infection.It was noted the device was implanted at the time of removal of the previous device for infection.Despite treatment with antibiotics, the infection persisted.No new device was implanted following removal of the malleable prosthesis.No additional patient complications were reported.

Manufacturer Narrative

Additional information and corrections provided to update the b5 describe event, h6 impact coding, and event date.

Event Description

It was reported that a surgical procedure was performed to remove this malleable penile prosthesis due to infection.It was noted the device was implanted at the time of removal of the previous device for infection.The patient was hospitalized for approximately a week.Despite treatment with antibiotics, the infection persisted for one month until it was resolved.No new device was implanted following removal of the malleable prosthesis.No additional patient complications were reported.

Event Description

It was reported that a surgical procedure was performed to remove this malleable penile prosthesis due to infection.During the procedure, the physician identified purulence from the right corpora.A culture sample was taken and the results came back positive for pseudomonas infection.It was noted the device was implanted at the time of removal of the previous device for infection.The patient was hospitalized for approximately a week.Despite treatment with antibiotics, the infection persisted for one month until it was resolved.No new device was implanted following removal of the malleable prosthesis.No additional patient complications were reported.

Manufacturer Narrative

Additional information and corrections provided to update the a2 age at time of event, a3 sex, b5 describe event, b7 other relevant history, h6 patient codes.

• 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: 19169487
• MDR Text Key: 340897862
• Report Number: 2124215-2024-24729
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005232
• UDI-Public: 00878953005232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2024

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 720056-01
• Device Catalogue Number: 720056-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/05/2024; 05/02/2024
• Supplement Dates FDA Received: 04/26/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male