MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 1012452-15

Device Problem Break (1069)

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

Event Date 01/27/2020

Event Type  malfunction  

Event Description

While using this coronary dilation balloon, some resistance was met in the stenosis.While trying to pass through the coronary lesion, the shaft of the dilation catheter snapped.The balloon was removed from the body and a new device was then opened and proceeded with the case.Manufacturer response for coronary dilation catheter, nc trek (per site reporter).Clinical representative aware and will stop in and evaluate device.

• Brand Name: NC TREK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 26531 ynez rd.; temecula CA 92591
• MDR Report Key: 9659189
• MDR Text Key: 177369458
• Report Number: 9659189
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012452-15
• Device Catalogue Number: 1012452-15
• Device Lot Number: 91114G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 102