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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR INC. TREK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY Back to Search Results
Model Number 1012280-15
Device Problems Migration or Expulsion of Device (1395); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2017
Event Type  malfunction  
Event Description
After final angioplasty, the balloon was withdrawn. It was noted the balloon embolized as it separated from the shaft. At that point, the left femoral arterial access was obtained. An over the wire long sheath was passed from the left femoral artery into the right common femoral. The embolized balloon was identified in the right superficial femoral artery (sfa) and with the help of a gooseneck snare, surgeons were able to safely capture and retrieve it. Bilateral groin accesses were closed with the angio-seal device.
 
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Brand NameTREK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez rd.
temecula CA 92591
MDR Report Key6903999
MDR Text Key87766510
Report Number6903999
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
Type of Report Initial
Report Date 09/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012280-15
Device Catalogue Number1012280-15
Device Lot Number50727G1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/06/2017
Event Location Hospital
Date Report to Manufacturer09/06/2017
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

Patient Treatment Data
Date Received: 09/29/2017 Patient Sequence Number: 1
Treatment
6-FRENCH SHEATH, 6-FRENCH FR4 GUIDING CATHETER, RU; CARDIAC DRUGS
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