MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION; PV BALLOON

Lot Number 40926G1

Device Problems Break (1069); Material Rupture (1546)

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

Event Date 12/15/2016

Event Type  malfunction  

Event Description

Abbott vascular nc trek coronary dilatation catheter ruptured pv balloon, shaft broke.Balloon retrieved.No harm.Ref (b)(4), lot 40926g1.

• Brand Name: NC TREK CORONARY DILATATION
• Type of Device: PV BALLOON
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 6193361
• MDR Text Key: 63081201
• Report Number: MW5066825
• Device Sequence Number: 1
• Product Code: LOX
• 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: 12/19/2016

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: No Information
• Device Expiration Date: 08/31/2017
• Device Lot Number: 40926G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 25