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

Model Number	720054-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis (spp) experienced pain at the surgical site, which led to a surgical intervention.During the procedure, the spp was removed and replaced with a tactra malleable penile prosthesis.There were no additional patient complications reported.
Additional Manufacturer Narrative
Device analysis pending closure.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this spp underwent a thorough analysis.The cylinders were visually inspected, microscopically examined, and functionally tested.Both cylinders had sharp instrument damage which likely occurred during explant; besides that, no anomalies were found.The cylinders performed within specification.Product analysis was unable to confirm the clinical observations.A review of the labeling confirmed the reported adverse events of pain is included in the product labeling.Additionally, there is no objective evidence that the user did not properly handle or use the device according to the spectra concealable penile prosthesis instructions for use (ifu).The reported events also do not contain an allegation against the labeling.
Event or Problem Description
It was reported that the patient with this spectra penile prosthesis (spp) experienced pain at the surgical site, which led to a surgical intervention.During the procedure, the spp was removed and replaced with a tactra malleable penile prosthesis.There were no additional patient complications reported.

• 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: 14079803
• Report Number: 2124215-2022-10725
• Device Sequence Number: 17528598
• Product Code: FAE
• UDI-Device Identifier: 00878953005201
• UDI-Public: 00878953005201
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: 05/25/2025
• Device Model Number: 720054-01
• Device Catalogue Number: 720054-01
• Device Lot Number: 1000428843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• 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: 67 YR
• Patient Sex: Male