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

Model Number	720054-02
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing difficulty with insertion during sexual intercourse with a spectra penile prosthesis (spp).The device cylinders were reported to bend, when having sexual intercourse.The spp was explanted, and a new spp was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Updated fields for d4 model number, d4 lot number, d4 catalog number, d4 expiration date, and d4 unique identifier.
Event or Problem Description
It was reported that the patient was experiencing difficulty with insertion during sexual intercourse with a spectra penile prosthesis (spp).The device cylinders were reported to bend, when having sexual intercourse.The spp was explanted, and a new spp was implanted.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt of these spectra penile prosthesis (spp) at our quality assurance laboratory, the returned components underwent a thorough analysis.Visual examination did not identify any leaks in the cylinders.Analysis identified both cylinders passed the bend test.Product analysis concluded these findings could not confirm the reported event.It was confirmed that no problem was detected with the spp.
Event or Problem Description
It was reported that the patient was experiencing difficulty with insertion during sexual intercourse with a spectra penile prosthesis (spp).The device cylinders were reported to bend, when having sexual intercourse.The spp was explanted, and a new spp was implanted.No patient complications were 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14502123
• Report Number: 2124215-2022-18289
• Device Sequence Number: 17400643
• 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: 2022
• 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): 08/03/2022

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: 1000433900
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 06/17/2022; 07/22/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/05/2022; 08/03/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male