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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR INC. TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 1012276-20
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/21/2019
Event Type  malfunction  
Event Description
Md inserting coronary dilatation catheter in the right femoral artery. The balloon got wrapped around the wire and the tip of the balloon snapped. Tried to snare the tip of the balloon however was unsuccessful. A right groin angiogram showed good flow in the external and common femoral artery with no flow limitation. Elected that this point to leave the tip of the balloon. Manufacturer response for coronary dilatation catheter, trek (per site reporter). Clinical representative aware: no response as of right now.
 
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Brand NameTREK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez rd.
temecula CA 92591
MDR Report Key9382568
MDR Text Key168219590
Report Number9382568
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012276-20
Device Catalogue Number1012276-20
Device Lot Number90408G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/22/2019
Device Age7 MO
Event Location Hospital
Date Report to Manufacturer11/27/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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