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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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ABBOTT VASCULAR NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 1012453-15
Device Problems Inflation Problem (1310); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 06/04/2018
Event Type  malfunction  
Event Description
Balloon had multiple successful inflation and deflation.On the last inflation, the device stayed inflated while in the vessel.After a short time the balloon came down in pressure just enough to move it into the guiding catheter.It became lodged in the catheter and unable to withdraw from the guider.The delivery system was then removed with the balloon still in the catheter.After the procedure was completed the balloon had come down in pressure and was able to be removed from the guiding catheter for further inspection and documentation.
 
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Brand Name
NC TREK
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
3200 lakeside drive
santa clara CA 95054 2807
MDR Report Key7609328
MDR Text Key111329859
Report Number7609328
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date03/31/2021
Device Model Number1012453-15
Device Catalogue Number1012453-15
Device Lot Number80419G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/11/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Weight98
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