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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER

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OSCOR INC. INTRODUCER KIT FOR IMPELLA® INTRODUCER, CATHETER Back to Search Results
Model Number 0052-3025
Device Problems Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aortic Dissection (2491)
Event Date 09/25/2019
Event Type  Injury  
Manufacturer Narrative
Our investigation is still in progress ,follow up report will be submitted if we find any further additional information.
 
Event Description
It was reported that patient was presented for ventricular tachachardia. During ep/ablation physician was advancing the guidewire through the introducer. Guidewire would not advance around ascending aorta. Diagnostic pigtail was inserted, prior to the insertion of the 0. 035" guidewire. Once pigtail was inserted, 0. 035 would not advance around ascending aorta. Again, dye showed a lumen and tortuous artery. Ep called for tee which showed a big flap from dissection of sfa to ascending aorta. Impella was aborted and wires removed and perclose x 2 failed and surgical closure was done after manual pressure did not yield good homeostasis. Procedure was aborted and patient outcome is stable.
 
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Brand NameINTRODUCER KIT FOR IMPELLA®
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
Manufacturer Contact
doug myers
3816 desoto blvd
palm habror, FL 34683
7279372511
MDR Report Key8768658
MDR Text Key150300087
Report Number1035166-2019-00057
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2021
Device Model Number0052-3025
Device Catalogue Number0052-3025
Device Lot NumberC1-15213
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2018
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: 07/08/2019 Patient Sequence Number: 1
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