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

Model Number	720054-02
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained that it was difficult to sustain intercourse with his spouse due to the spectra penile prosthesis (spp) bent.The device was replaced with a new spp.The size of the previous device was appropriate for the patient.The patient improved and had a good outcome following the procedure.
Event or Problem Description
It was reported that the patient complained that it was difficult to sustain intercourse with his spouse due to the spectra penile prosthesis (spp) bent.The device was replaced with a new spp.The size of the previous device was appropriate for the patient.The patient improved and had a good outcome following the procedure.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported device issue was not confirmed.The spectra cylinders performed within specifications.Device history record (dhr): the device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the spectra cylinders were visually inspected, microscope examined and functionally tested; no visual damages were found upon inspection.Both cylinders passed the bend test.The cylinders therefore performed within specification.Product analysis was unable to confirm the reported event.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion: based on the information available, a conclusion code of no problem detected was assigned to this investigation.

• 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
• MDR Report Key: 11885303
• Report Number: 2124215-2021-14894
• Device Sequence Number: 3748396
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 05/06/2025
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000426314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR