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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER

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OSCOR INC. ABIOMED 14F INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemostasis (1895); Blood Loss (2597)
Event Date 02/08/2019
Event Type  Injury  
Manufacturer Narrative
Device used in treatment. The device was not returned for analysis. There was no specific performance related failure reported by the user. The lot number of this device was not provided, therefore neither a review of the device history record nor complaint history could be performed. Inspection procedures require any oscor product pass all in-process and qa final inspections before shipping to the customer. As per ifu: directions for use: introducer removal flush the sheath with 5 cc of saline immediately before peeling the sheath away in order to minimize back bleeding. First, completely withdraw the sheath from the vessel. Then remove the sheath by sharply snapping the tabs of the valve housing in a plane perpendicular to the long axis of the sheath to split the valve and peel the sheath apart. As per ifu: bedding is possible complications/adverse effects. Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity. The event will be re-evaluated if additional information becomes available. No further follow-up is require.
 
Event Description
It was reported that patient was presented to the physician for ami w/shock-impella post-pci. During the procedure sheath placed to left femoral artery, when long sheath (14f) was peeled away, bleeding happen. There was 300cc blood lost and rbc 2u transfusion was made. No additional surgery or medical intervention required to control the blood loss. Bleeding was treated with manual compression hemostasis and inserted a sheath for insertion. There was unknown time of delay reported because of blood transfusion. There was no specific device performance failure reported by the user, the peel away sheath peeled all the way through. Impella support was successful and patient outcome is stable. No additional information is available and no other adverse event reported.
 
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Brand NameABIOMED 14F INTRODUCER 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 habror FL 34683
Manufacturer Contact
doug myers
3816 desoto blvd
palm habror, FL 34683
7279372511
MDR Report Key8401049
MDR Text Key138144760
Report Number1035166-2019-00022
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,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/07/2019 Patient Sequence Number: 1
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