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

Model Number 720054-02

Device Problem Insufficient Information (3190)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 10/29/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to inflammation with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.

Event Description

It was reported that the patient underwent a revision procedure due to inflammation and pain with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.

Manufacturer Narrative

Product analysis was unable to confirm the reported events.The spectra cylinders were visually and functionally tested.Cylinder 1 has sharp instrument/tool damage to the outer tube, which resulted in a hole and exposed metal segments.This damage is consistent with explant damage and it will be considered a secondary failure.Both cylinders were functionally tested and passed the bend test with a force readout of less than 1390 grams.The cylinders therefore performed within specification.Product analysis was unable to confirm the reported events.A labeling review confirmed that inflammation and pain are both noted as potential adverse events.Therefore, the evaluation conclusion code of known inherent risk of device was assigned to this event.

Event Description

It was reported that the patient underwent a revision procedure due to inflammation and pain near the genitals with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.

Event Description

It was reported that the patient underwent a revision procedure due to inflammation and pain near the genitals with an spectra penile prosthesis (spp).The spp was explanted and the physician treated the inflammation and a new spp was implanted.The cause of the inflammation was unknown from the hospital.The patient was stable following the procedure.

• 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
• MDR Report Key: 10824652
• MDR Text Key: 215886986
• Report Number: 2183959-2020-05433
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005218
• UDI-Public: 00878953005218
• Combination Product (y/n): N
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/15/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2024
• Device Model Number: 720054-02
• Device Catalogue Number: 720054-02
• Device Lot Number: 1000278662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 11/16/2020; 12/08/2020
• Supplement Dates FDA Received: 11/16/2020; 11/24/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR