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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION AVIATOR PLUS .014 5.0X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION AVIATOR PLUS .014 5.0X20 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 4245020W
Device Problem Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. This device is available for analysis but the device has not yet been received. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, after opening the outer package of the aviator plus. 014 5. 0x20 142cm, it was found that the inner package of the balloon product was not well sealed. The product was stored in the hospital equipment cabinet, and the barcode on the outer packaging is removed and pasted on the patient surgical information record file when used. In this case, there was no trace of the barcode that had been removed before the outer packaging was opened. There was no reported patient injury. The balloon was replaced with another balloon. The intended procedure was a balloon dilation of pulmonary hypertension. The device was stored in the lab in a constant temperature and humidity equipment cabinet. The product will be returned for evaluation.
 
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Brand NameAVIATOR PLUS .014 5.0X20 142CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12682972
MDR Text Key279314365
Report Number9616099-2021-04997
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K071189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4245020W
Device Catalogue Number4245020W
Device Lot Number82214871
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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