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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSCOR INC. GUIDESTAR STEERABLE GUIDING SHEATH INTRODUCER, CATHETER

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OSCOR INC. GUIDESTAR STEERABLE GUIDING SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number D141101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non specific EKG/ECG Changes (1817)
Event Date 09/16/2020
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, after placing guidestar steerable sheath into the left atrium the transient st elevation happened. Medication required to treat st elevation. Cause of the st elevation is unknown. No other patient side effects reported. No additional information is available.
 
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Brand NameGUIDESTAR STEERABLE GUIDING SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 desoto blvd
palm harbor FL 34683
Manufacturer Contact
doug myers
3816 desoto blvd
palm harbor, FL 34683
7279372511
MDR Report Key10819552
MDR Text Key215619496
Report Number1035166-2020-00073
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00885672009496
UDI-Public00885672009496
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140406
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 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD141101
Device Catalogue NumberD141101
Device Lot NumberOR-04983
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/03/2019
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: 11/10/2020 Patient Sequence Number: 1
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