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

Model Number 720074-03

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Product investigation completed.As the complaint component was not returned for analysis, no product analysis could be performed.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa or scar is required.

Event Description

It was reported that the patient experienced sizing issues with an spectra penile prosthesis (spp) as the device would not reach mid glans.A replacement surgery was performed in which the existing device was removed and a new spp was implanted.There were no device malfunctions associated with the explanted device.The patient did not experience any adverse events.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS PENILE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS LLC; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4083953452
• MDR Report Key: 10469919
• MDR Text Key: 204860776
• Report Number: 2183959-2020-03846
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005294
• UDI-Public: 00878953005294
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/24/2022
• Device Model Number: 720074-03
• Device Catalogue Number: 720074-03
• Device Lot Number: 0185622003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR