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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS STENT BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL

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CORDIS CORPORATION AVIATOR PLUS STENT BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL Back to Search Results
Model Number 300691
Device Problems Wire (430); Device Slipped (1584); Physical Resistance (2578)
Patient Problem No Code Available (3191)
Event Date 01/20/2014
Event Type  Injury  
Event Description

During cardiac catheterization the balloon shaft remained in the patient, which required transferring the patient to the or for surgical removal. The right brachial artery was accessed. At one point, a 6x20 aviator plus was used to work on the superficial femoral stenosis. There was difficulty passing the balloon distally and a loop was visualized in the shoulder subclavian area. Attempts were made to withdraw the balloon to reduce the loop, but were unsuccessful. The procedure was aborted. Attempts were made to pull the catheter, but significant resistance was felt. The sheath was removed in an attempt to try to take the whole system out without success. The patient was taken to the or for removal of the retained balloon. Findings at surgery reflect that the balloon wire was looped in the intima and the lumen of the brachial artery above and below the antecubital space. The device was removed through two separate incisions. There were no further complications post procedure.

 
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Brand NameAVIATOR PLUS STENT BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL
Manufacturer (Section D)
CORDIS CORPORATION
6500 paseo padre parkway
freemont CA 94555
MDR Report Key3631464
MDR Text Key4178876
Report Number3631464
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/28/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/29/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number300691
Device LOT NumberH7394246030W215845144
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/29/2014
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer02/18/2014

Patient TREATMENT DATA
Date Received: 01/29/2014 Patient Sequence Number: 1
Treatment
CATHETER, CUTTING BALLOON.; GLIDESHEATH WIRES, DIAGNOSTIC J WIRE, PIGTAIL
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