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

Model Number	720054-02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to clinic following erosion at the distal tip of the penis involving this spectra penile prosthesis (spp).Upon confirmation by the physician, a surgical procedure was performed during which the spp was explanted.No additional patient complications were reported.
Event or Problem Description
It was reported that the patient presented to clinic following erosion at the distal tip of the penis involving this spectra penile prosthesis (spp).Upon confirmation by the physician, a surgical procedure was performed during which the spp was explanted.No additional patient complications were reported.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific cannot determine the most probable cause of the erosion.Product analysis did not identify any device characteristics that would cause or contribute to the reported clinical observations.However, erosion is including in product labeling as a potential harm associated with inflatable penile prosthesis (ipp) procedures.Device history record review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: upon receipt at our post market quality assurance laboratory, the spectra penile prosthesis (spp) was thoroughly inspected and analyzed.Visual and microscopic inspection noted sharp instrument/tool damage to the outer tube in both distal cylinder bodies resulting in holes and exposed metal segments; the damage was consistent with that observed during explant.Functional testing of both cylinders found they performed within specification.Product analysis did not identify any device anomalies.Labeling review: erosion is listed as a potential adverse event in the instructions for use (ifu).Review of labeling determined the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to the labeling.The manual was unlikely to be the cause of the reported complaint.Investigation conclusion: no further actions are considered necessary and the complaint investigation conclusion code is known inherent risk of device.

• 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: 13830441
• Report Number: 2124215-2022-07912
• Device Sequence Number: 1308655
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 07/14/2024
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000303988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male