MAUDE Adverse Event Report: IRVINE BIOMEDICAL, INC. ST JUDE COOL POINT TUBING; CATHETER, PERCUTANEOUS, CARDIAC ABLATION FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number 85785

Device Problem Crack (1135)

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

Event Date 02/17/2020

Event Type  malfunction  

Event Description

Upon spiking heparinized saline flush bag to prime tubing, product found to have crack in tubing, creating an area where fluid would leak.Fda safety report id# (b)(4).

• Brand Name: ST JUDE COOL POINT TUBING
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): IRVINE BIOMEDICAL, INC. ; irvine CA
• MDR Report Key: 9779757
• MDR Text Key: 182223082
• Report Number: MW5093478
• Device Sequence Number: 1
• Product Code: OAD
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 85785
• Device Lot Number: H1742412
• Was Device Available for Evaluation?: No
• 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