MAUDE Adverse Event Report: ABBOTT TREK CORONARY DILATATION CATHETER; CATHETERS, TRANSLUMINAL

Catalog Number 1012278-12

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  malfunction  

Event Description

Ptca balloon became stuck when attempting to withdraw the device from the prox lad.Md had to use much more force than necessary to remove.We had to remove the guide catheter, guidewire and balloon, all as one unit from the body.It was then noticed the balloon was bunched up at the tip of the guide, preventing the balloon from being pulled into the guide.F/u angis showed no disruption of the vessel.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CATHETERS, TRANSLUMINAL
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 7230553
• MDR Text Key: 98764634
• Report Number: MW5074981
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 1012278-12
• Device Lot Number: 61007G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 49 YR