MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12; STENT, RENAL

Model Number 85365

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received stated the stent could not be released from the balloon.

Manufacturer Narrative

A complaint investigation could not be conducted as the device that was received was not an atrium medical product.The product received was a stent delivery system with a stent in place on the catheter shaft.It would appear that there was some confusion in regards to the product that was being used by the institution.Correspondence received stated the v12 device is not available and there is no further information provided from the facility.

• Brand Name: ADVANTA V12
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7531001
• MDR Text Key: 108986379
• Report Number: 3011175548-2018-00499
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 243412
• Device Age: YR
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/21/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR