MAUDE Adverse Event Report: ABBOTT VASCULAR COSTA RICA NC-TREK 4.5 X 12 BALLOON; CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY

Catalog Number 1012454-12

Device Problem Retraction Problem (1536)

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

Event Date 01/24/2019

Event Type  malfunction  

Event Description

After deflation of the balloon, the balloon was unable to be pulled back into the guide catheter.

• Brand Name: NC-TREK 4.5 X 12 BALLOON
• Type of Device: CATHETER TRANSLUMINAL CORONARY ANGIOPLASTY
• Manufacturer (Section D): ABBOTT VASCULAR COSTA RICA; CS
• MDR Report Key: 8624806
• MDR Text Key: 145754283
• Report Number: MW5086766
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012454-12
• Device Lot Number: 80810G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 134