MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number 1012452-12

Device Problems Sticking (1597); Failure to Advance (2524)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

The tip protector on end of dilation balloon would not slide off.Once the tip was finally removed, the balloon would not slide over the guidewire.Balloon not used on patient and never entered body.

• Brand Name: NC TREK RX CORONARY DILATATION CATHETER
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 4745271
• MDR Text Key: 5823434
• Report Number: 4745271
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1012452-12
• Device Lot Number: 50210G1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2015
• Patient Sequence Number: 1