MAUDE Adverse Event Report: ST. JUDE MEDICAL PRESSUREWIRE AERIS AGILE TIP; DIAGNOSTIC AND PROCEDURAL WIRE

Model Number IC 8466A-2

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/21/2017

Event Type  malfunction  

Event Description

During the process to place stent using the pressurewire aeris agile tip, the distal portion of the wire tip measuring approximately 3 cm dislodged.The tip of the wire was successfully jailed with the implantation of 3 additional drug-eluting stents in the rca territory.Diagnosis or reason for use: obstructive coronary disease in rca.Pressurewire aeris agile tip.(b)(6) 2017.

• Brand Name: PRESSUREWIRE AERIS AGILE TIP
• Type of Device: DIAGNOSTIC AND PROCEDURAL WIRE
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 6954523
• MDR Text Key: 89695869
• Report Number: MW5072778
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2017

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: 07/31/2018
• Device Model Number: IC 8466A-2
• Device Catalogue Number: 05414734055772
• Device Lot Number: 5617154
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 80