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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemostasis (1895); Blood Loss (2597)
Event Date 05/28/2019
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
On (b)(6) 2019, patient was presented to physician for cardiac arrest with intermittent return of spontaneous circulation during ems and er intervention. Approximately 1 day after, during acute myocardial infarction / cardiogenic shock, impella implanted and introducer peeled away. As per reported event, introducer was peeled while still in patient's vessel, causing the bleed. Hemostasis was achieved and patient was in stable condition. 3 units of blood products were given. Procedure completed successfully with impella cp device. No new introducer was needed. Blood products delivered approximately 1 day after introducer was removed.
 
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Brand NameINTRODUCER KIT FOR IMPELLA®
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd
palm habror FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor FL 34683 1816
Manufacturer Contact
doug myers
3816 desoto blvd
palm habror, FL 34683
7279372511
MDR Report Key8760516
MDR Text Key150030200
Report Number1035166-2019-00056
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
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2022
Device Model Number0052-3025
Device Catalogue Number0052-3025
Device Lot NumberC1-16097
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2019
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: 07/03/2019 Patient Sequence Number: 1
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