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

Model Number	720074-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed due to an infection.A new tactra penile prosthesis was implanted.Following the surgery, the patient was stable and the event resolved.
Additional Manufacturer Narrative
Investigation summary: based on the information available, the cause that contributed to the reported infection could not be established as the product is not available for analysis.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.A risk review confirmed that the event is accounted for in the risk documentation.Device technical analysis: the device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not review any evidence of device off-label use or failure to follow instructions.Infection is documented as adverse events.Investigation conclusion: based on this investigation and all information available, a conclusion code of known inherent risk of device was assigned to this investigation.Risk review and labeling review identified that the adverse event of infection is a known risk of the device.The cause of the infection was not established by physician, although infection is included in the labelling documentation for infection device as an adverse event of implant surgical procedure of device and also the risks, benefits, and potential adverse events of all available treatment options should be discussed with the patient and considered by the physician and patient when choosing a treatment option is included in the document, therefore a conclusion code of known inherent risk of device was chosen.
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed due to an infection.A new tactra penile prosthesis was implanted.Following the surgery, the patient was stable and the event resolved.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, the cause that contributed to the infection issue was not confirmed.Device history record review (dhr): the device history record review (dhr) confirmed that the device met all material, assembly and performance specifications.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Additionally, the reported events do not contain an allegation against the labeling.Device technical analysis: upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.The spectra penile prosthesis (spp) cylinders were visually inspected, microscope examined and functionally tested and no visual damages were found upon inspection.Both cylinders passed the bend test with a force readout of less than 1390 grams.The cylinders, therefore, performed within specification.Product analysis was unable to confirm the reported events.Labeling review: a labeling review was performed and according to the app instruction for use document, infection is documented as an adverse event.Also, there is no evidence that the device was used or handled improperly.Investigation conclusion: based on this investigation a clear probable cause for the event was established; therefore, the investigation conclusion code of known inherent risk of device was chosen, as infection is included in the product labeling and hazard analysis.
Event or Problem Description
It was reported that the patient had the spectra penile prosthesis removed due to an infection.A new tactra penile prosthesis was implanted.Following the surgery, the patient was stable and the event resolved.

• 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 ; 4089353452
• MDR Report Key: 13100392
• Report Number: 2124215-2021-38927
• Device Sequence Number: 2047766
• 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: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/08/2021
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 0155876001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 01/07/2022; 02/04/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/28/2022; 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2016
• 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: 76 YR
• Patient Sex: Male