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

Model Number	720054-03
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Perforation (2001)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's spectra penile prosthesis was extruding on the left side through the urethra, with no evidence of local infection.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes, based on analysis results, product analysis was unable to confirm the reported migration, extrusion and perforation.Device history record review (dhr): review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Label review: a labeling review was performed and according to the spectra ifu, extrusion and perforation are documented as adverse events.Also, there is no evidence that the device was used or handled improperly.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 cylinder was visually inspected, microscope examined and functionally tested; no visual damages were found upon inspection.The cylinder passed the bend test with a force readout of less than 1390 grams.The cylinder therefore performed within specification.Product analysis was unable to confirm the reported 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.
Event or Problem Description
It was reported that the patient's spectra penile prosthesis was extruding on the left side through the urethra, with no evidence of local infection.The device was explanted.

• 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: 9680642
• Report Number: 2183959-2020-00477
• Device Sequence Number: 2667928
• Product Code: FAE
• UDI-Device Identifier: 00878953005225
• UDI-Public: 00878953005225
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 08/30/2021

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: 05/24/2021
• Device Model Number: 720054-03
• Device Catalogue Number: 720054-03
• Device Lot Number: 0138238002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR