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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH DYB INTRODUCER, CATHETER

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COOK INC PERFORMER MULLINS GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); ST Segment Elevation (2059)
Event Date 02/28/2018
Event Type  Injury  
Manufacturer Narrative
Common name & product code
=
unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number
=
unavailable as the device lot number, rpn, and gpn are unknown. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported, during an atrial fibrillation procedure, the patient experienced st elevation and an air embolism occurred. Two difficult transseptal punctures were performed under fluoroscopic and intracardiac echocardiography (ice) guidance with short bursts of cauterization. The first transseptal sheath was inadvertently withdrawn to the right atrium. Shortly after, st elevation was observed on the inferior leads and air was visualized on fluoroscopy. 100% fio2 was administered and the st elevation resolved. The ablation catheter was inserted into the patient and the procedure was completed successfully. The patient is in stable condition. The physician was unable to confirm the cause of the air embolism. Three total sheaths were used, two of another manufacturer's and one cook mullins sheath. The device information was unable to be retrieved.
 
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Brand NamePERFORMER MULLINS GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8459971
MDR Text Key140167187
Report Number1820334-2019-00626
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/28/2019 Patient Sequence Number: 1
Treatment
ABBOTT SHEATHS (2)
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