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U.S. Department of Health and Human Services

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

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OSCOR INC. DESTINO TWIST STEERABLE GUIDING SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number DST1387139
Device Problem Leak/Splash (1354)
Patient Problems Cardiac Arrest (1762); ST Segment Elevation (2059)
Event Date 10/08/2019
Event Type  Injury  
Manufacturer Narrative
Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.
 
Event Description
Patient was presented for treatment of paroxysmal atrial fibrillation with the coolloop cryoablation system (afreeze). Air embolism was observed approximately 1. 5 min after removal of the transseptal needle and dilator. According to the physician possible air ingress via the sheath. Patient developed st-segment elevations and went into cardiac arrest. Procedure was terminated immediately, 13 minute reanimation with return of spontaneous circulation. The next day, the patient was transferred to the cardiologic ward. Patient has fully recovered.
 
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Brand NameDESTINO TWIST 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 Key9297149
MDR Text Key185289134
Report Number1035166-2019-00094
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K140406
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/01/2021
Device Model NumberDST1387139
Device Catalogue NumberDST1387139
Device Lot NumberC8-15072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
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: 11/08/2019 Patient Sequence Number: 1
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