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

Model Number	720074-01
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgical procedure to replace this undersized spectra penile prosthesis (spp).During surgery, it was noted that there was pending lateral erosion in the penis, which is believed to be related to the sizing issues.The entire spp was removed and replaced with a inflatable penile prosthesis.No patient complications were reported.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to replace this undersized spectra penile prosthesis (spp).During surgery, it was noted that there was pending lateral erosion in the penis, which is believed to be related to the sizing issues.The entire spp was removed and replaced with a inflatable penile prosthesis.No additional patient complications were reported.
Additional Manufacturer Narrative
Investigation summary: based on the information available, there was no device available for analysis.The reported patient symptoms are known risks associated with spp procedures and are noted as such in the spp instructions for use.Device history record (dhr) review: the dhr confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the spp ifu was reviewed.The patient symptom of erosion was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device 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
• 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: 13490183
• Report Number: 2124215-2022-03961
• Device Sequence Number: 20009858
• Product Code: FAE
• UDI-Device Identifier: 00878953005270
• UDI-Public: 00878953005270
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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: Health Professional
• Device Expiration Date: 02/04/2020
• Device Model Number: 720074-01
• Device Catalogue Number: 720074-01
• Device Lot Number: 921383005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2015
• 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: 71 YR
• Patient Sex: Male