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

Model Number	720074-02
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had this tactra device replaced with a spectra since the patient claimed dissatisfaction as the device was not firm enough during intercourse.There were no patient complications reported.
Event or Problem Description
It was reported that the patient had this spectra device replaced with a tactra since the patient claimed dissatisfaction as the device was not firm enough during intercourse.There were no patient complications reported.
Additional Manufacturer Narrative
Product information in tab d and b3 describe event or problem were corrected as the device was a spectra that was replaced with a tactra.
Event or Problem Description
It was reported that the patient had this spectra device replaced with a tactra since the patient claimed dissatisfaction as the device was not firm enough during intercourse.There were no patient complications reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this spectra penile prosthesis underwent a thorough analysis.The cylinders were visually and microscopically examined, and functionally tested.No anomalies were found with the cylinders.Based on the information available and analysis results, product analysis was unable to confirm the reported clinical observation of mechanical non conformance.

• 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
• MDR Report Key: 14918302
• Report Number: 2124215-2022-24057
• Device Sequence Number: 11270696
• 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: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2022

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: Lay User/Patient
• Device Expiration Date: 06/04/2019
• Device Model Number: 720074-02
• Device Catalogue Number: 720074-02
• Device Lot Number: 886203004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/05/2022; 08/17/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/06/2022; 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2014
• 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