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U.S. Department of Health and Human Services

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

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OSCOR INC. ABIOMED INTRODUCER KIT FOR IMPELLA INTRODUCER, CATHETER Back to Search Results
Model Number 0052-3001
Device Problem Fluid/Blood Leak (1250)
Patient Problems Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Tachycardia (2095); Cardiogenic Shock (2262)
Event Date 06/10/2020
Event Type  malfunction  
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up report will be submitted as soon as the investigation is complete.
 
Event Description
It was reported patient came from intensive care unit (icu) in a rather critical state. The 23f sheath was used for acute myocardial infraction (ami) and a cardiogenic shock (cgs) procedure. Issue with the 23f sheath was bleeding through the valve, it was identified when sheath was inserted into the femoral vein, physician tried to stop bleeding with 0. 027" wire (different vendors product), then 12f sheath, then rp pump (in that order) unsuccessfully. Only brief delay of the procedure due to bleeding, no impact on patient condition. Patient outcome is death ((b)(6) 2020), however, death is not related to device failure. Physician reported cause of patient death as ventricular tachycardia (attempts to achieve sinusrhythm were unsuccessful) followed by no output from left ventricle (lv). Additionally, the physician said that the blood loss was not contributing to the death of the patient since it was not therapeutically relevant.
 
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Brand NameABIOMED INTRODUCER KIT FOR IMPELLA
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd.
palm harbor, fl
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd.
palm harbor, fl
Manufacturer Contact
doug myers
3816 desoto blvd.
palm harbor, fl 
9372511
MDR Report Key10259632
MDR Text Key202010147
Report Number1035166-2020-00040
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00813502011517
UDI-Public00813502011517
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,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Model Number0052-3001
Device Catalogue Number0052-3001
Device Lot NumberC1-14497
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/02/2018
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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