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

Model Number	720074-02
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent inflatable penile prosthesis replacement surgery as the device bent during sexual intercourse and it was difficult to insert.The patient outcome was reported to be stable following the surgery.
Additional Manufacturer Narrative
B3.Actual event date is unknown.
Event or Problem Description
It was reported that the patient underwent inflatable penile prosthesis replacement surgery as the device bent during sexual intercourse and it was difficult to insert.The patient outcome was reported to be stable following the surgery.
Additional Manufacturer Narrative
B3.Actual event date is unknown.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Additional Manufacturer Narrative
B3.Actual event date is unknown.Upon receipt of this spectra concealable penile prosthesis at our quality assurance laboratory, the returned components underwent a thorough analysis.Both spectra cylinders were visually inspected and functionally tested.Both cylinders had gaps between the two longer distal segments of the cylinder.Cylinder one and cylinder two both passed the bend test.Product analysis was unable to confirm reported allegation as both spectra cylinders performed within specification.Based on the analysis results, an investigation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent inflatable penile prosthesis replacement surgery as the device bent during sexual intercourse and it was difficult to insert.The patient outcome was reported to be stable following the surgery.

• 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: 17736339
• Report Number: 2124215-2023-49874
• Device Sequence Number: 5889328
• Product Code: FAE
• UDI-Device Identifier: 00878953005287
• UDI-Public: 00878953005287
• 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: 2013
• 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,Followup
• Report Date (Section B): 02/15/2024

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: 09/11/2017
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 791053004
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 09/27/2023; 01/30/2024
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/17/2023; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RTE: 72404321/787543018.; RTE: 72404321/787543018.; RTE: 72404321/787543018.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male