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U.S. Department of Health and Human Services

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

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OSCOR INC. DESTINO REACH STEERABLE GUIDING SHEATH INTRODUCER, CATHETER Back to Search Results
Model Number DCR0857722
Device Problem Air Leak (1008)
Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative
Country of incident occurrence - (b)(6). A preliminary review showed there were no manufacturing rejects or anomalies of this event type recorded in the device history record. The product in question has been received and has entered the investigation process. Conclusion not yet available as the investigation is on-going.
 
Event Description
The customer reported at the beginning of the pvi procedure, the physician detected st elevation in the surface ecg during the use of destino reach shortly after transseptal puncture. According to the physician, this st elevation is due to an air embolism through the steerable sheath. The air entry itself was not directly observed or noticed. Destino has been flushed and aspirated. As st elevation has been observed an ablation catheter was already in the sheath (biosense webster thermocool smarttouch sf with 2ml/h active flushing). St elevation disappeared after one minute hyperstimulation of patient. The patient was not subjected to procedures which might have damaged the device, and the event did not cause an adverse change to the patient's condition.
 
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Brand NameDESTINO REACH STEERABLE GUIDING SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
OSCOR INC.
3816 de soto blvd.
palm harbor FL 34683
Manufacturer (Section G)
OSCOR INC.
3816 de soto blvd.
palm harbor FL 34683
Manufacturer Contact
dorit segal
3816 de soto blvd.
palm harbor, FL 34683
MDR Report Key7607334
MDR Text Key111307472
Report Number1035166-2018-00054
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00885672007232
UDI-Public00885672007232
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K151951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/01/2021
Device Model NumberDCR0857722
Device Catalogue NumberDCR0857722
Device Lot NumberC8-12996
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2018
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: 06/15/2018 Patient Sequence Number: 1
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