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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 6.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION AVIATOR PLUS .014 6.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4246040W
Device Problem Burst Container or Vessel (1074)
Patient Problems Stroke/CVA (1770); Extravasation (1842)
Event Date 02/26/2020
Event Type  Injury  
Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available. A review of the manufacturing documentation associated with lot 17672697 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the aviator plus. 014¿ 6. 0mmx40mm 142cm was inserted and blown up to nominal pressure. However, the balloon broke at nominal pressure because of the large calcified plaque in vessel. There was an injury to the patient. They took picture and saw large extravasation. Sheath, angioguard, and stent were placed with no issues. The sheath was exchanged and non-cordis covered stent was placed, followed by 6x40 non-cordis balloon. No extravasation seen on post picture in 2 angles. According to the surgeon, there was plaque rupture with the deployment of stenting and balloon angioplasty. The heavily calcified plaque may have caused the balloon to rupture. The patient required a secondary procedure, stenting with covered stent x 2. As per the sales rep, the patient experienced symptoms of a stroke, the patient was non-verbal/non-motor responses and was sent directly to catscan. The patient began recovering motor functions during the scan. The lesion had moderate to severe plaque calcification. There was no vessel tortuosity. The percentage of stenosis was greater than 50%. The device was not used for a chronic total occlusion and was stored and handled per the instructions for use (ifu). The device was prepped normally per ifu by maintaining. There was no difficulty of removing the stylet or any of the sterile packaging components, removing the product from the hoop, removing the protective balloon cover. There were no kinks or other damages noted prior to inserting the product into the patient. The same indeflator was used successfully with other devices. There was no resistance/friction noted while inserting the balloon through the rotating hemostatic valve. There was no difficulty advancing the balloon catheter through the vessel and difficulty crossing the lesion. The products were removed intact in one piece from the patient. The device is expected to be returned for evaluation. Concomitant medical products: unknown sheath; viabahn covered stent; mustang balloon.
 
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Brand NameAVIATOR PLUS .014 6.0X40 142CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key9889468
MDR Text Key190379115
Report Number9616099-2020-03604
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model Number4246040W
Device Catalogue Number4246040W
Device Lot Number17672697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/27/2020 Patient Sequence Number: 1
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