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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. ABIOMED INTRODUCER 23F S30CM D37CM TKIT INTRODUCER, CATHETER

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OSCOR INC. ABIOMED INTRODUCER 23F S30CM D37CM TKIT INTRODUCER, CATHETER Back to Search Results
Model Number 0052-3021
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problems Hemostasis (1895); Blood Loss (2597)
Event Date 02/21/2019
Event Type  Injury  
Manufacturer Narrative
Our investigation is still in progress ,follow up report will be submitted if we found any further additional information.
 
Event Description
It was reported that during cardiomyopathy sheath was leaking. Physician attributed this issue due to a potential crack in the introducer. After unscrewing and taking dilator out carefully, physician attempted to place impella rp through it and it started bleeding and impella rp not able to advance into left pulmonary artery. User removed the impella and sheath was exchanged, impella insertion went smoothly. It was reported that approximately 100 cc blood was lost and cardiothoracic surgeon physician's assistant purse string suture with good hemostasis. Patient received successful support, thereafter. No additional information is available and no other adverse event reported.
 
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Brand NameABIOMED INTRODUCER 23F S30CM D37CM TKIT
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
Manufacturer Contact
doug myers
3816 desoto blvd
palm habror, FL 34683
7279372511
MDR Report Key8463777
MDR Text Key140284057
Report Number1035166-2019-00029
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 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2021
Device Model Number0052-3021
Device Catalogue Number0052-3021
Device Lot NumberC1-14257
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
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: 03/29/2019 Patient Sequence Number: 1
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