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

Model Number	720054-02
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that the patient underwent a procedure.To remove the ams spectra concealable penile prosthesis, because the device was bending.The device was replaced with a tactra malleable penile prothesis.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned device underwent a thorough analysis.Noth cylinders were visually inspected, and functionally tested.Visual examination revealed that both cylinders had holes in the distal of their bodies with internal component exposed, consistent with explant damage.In addition, it was noted that there were yellow specks on the body of cylinder 1.Both cylinders passed the functional inspection.Based on the information available and analysis results, the reported clinical observation of device bending could not be confirmed; therefore, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent a procedure to remove the ams spectra concealable penile prosthesis because the device was bending.The device was replaced with a tactra malleable penile prothesis.There were no 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17131443
• Report Number: 2124215-2023-30688
• Device Sequence Number: 6457642
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 08/22/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/06/2025
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000433930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2020
• 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: 59 YR
• Patient Sex: Male