MAUDE Adverse Event Report: ABBOTT VASCULAR PILOT 50 GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number PILOT 50, LOT# NOT AVAILABLE

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during the procedure the physician had problems inserting a abbott pilot 50 coronary guidewire into the left ventricular (lv) lead from the lead's connector pin.There was a resistance that was very difficult to overcome after about 10 to 15 centimeters.Both lead and the guidewire were removed and replaced.A new lead and abbott pilot 50 used.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PILOT 50 GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 17489006
• MDR Text Key: 320706479
• Report Number: MW5121705
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: PILOT 50, LOT# NOT AVAILABLE
• Patient Sequence Number: 1