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

Model Number	720056-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Unspecified Heart Problem (4454); Unspecified Kidney or Urinary Problem (4503)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Additional information and corrections provided to update the b5 describe event, h6 impact coding, and event date.
Event or Problem 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 or Problem 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.
Event or Problem Description
It was reported that this patient, participating in the it matters clinical study, underwent surgical procedure to implant this malleable penile prosthesis, when the physician identified purulence from the right corpora.A culture sample was taken, and the results came back positive for pseudomonas infection.Antibiotics were prescribed and the patient was discharged.Approximately a month later the patient returned with persistent dull penile pain that was improving.A month and a half later, the patient presented with the same penile pain, but no signs of infection.The patient was prescribed another antibiotic, and a device replacement was scheduled.A week later, the patient called the physician with worsening pain and was admitted to the hospital for pain control, antibiotics, and device explant.Upon explant, immediate expression of purulence from the right corpora was noted and irrigation was performed.A sample culture tested positive for staph epidermis, staph aureus, and pseudomonas.The pain improved and antibiotics were prescribed.Due to the patient's heart condition, an echocardiogram was performed and resulted in right heart catheterization complicated by mild contrast induced acute kidney injury.The patient was given fluid and prescribed oral antibiotics at discharge.
Additional Manufacturer Narrative
Additional information updated b5 describe event or problem and h6 patient codes.

• 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: 19169487
• Report Number: 2124215-2024-24729
• Device Sequence Number: 12747372
• Product Code: FAE
• UDI-Device Identifier: 00878953005232
• UDI-Public: 00878953005232
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/23/2024

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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 05/02/2024; 07/08/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 04/26/2024; 05/16/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male