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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 Problems Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Event Date 03/22/2022
Event Type  Injury  
Event Description
Heliostar ee - after sheath exchange (sl1 for guidestar), st elevation was observed on the ecg, leading after some minutes to several vf episodes. Systolic blood pressure dropped to 3. 5-4 and a coronarography was performed. It showed a possible coronary spasm in the descendant anterior part of the left coronary artery. Also, the patient had an ischemic episode in the past that was visible in the coronarography but had nothing to do with this adverse event after 30-40 minutes, ecg came back to normal and bp was stabilized. Af procedure was suspended. No patient consequences were reported. No additional information is available.
 
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
 
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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 Key14141260
MDR Text Key289497027
Report Number1035166-2022-00054
Device Sequence Number1
Product Code DYB
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 Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberD141101
Device Catalogue NumberD141101
Device Lot NumberC8-19616
Was Device Available for Evaluation? No
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2020
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: 04/19/2022 Patient Sequence Number: 1
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