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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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TELEFLEX INCORPORATED ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number IPN038164
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoxia (1918); Respiratory Distress (2045); Coma (2417); Loss of consciousness (2418)
Event Date 10/20/2018
Event Type  Injury  
Event Description
Called to bedside as patient deteriorated rapidly during internal jugular central line removal. Patient became stuporous and with agonal breathing, severe hypoxemia ensued and supported him with ambu bag and 100% oxygen immediately. Eyes were noted to be fixed and deviated to upper left and unresponsive to stimuli. Patient then started to breathe spontaneously with normal respiratory effort but remained comatose. Bedside echocardiography revealed significant amount of air bubbles in the right heart. Patient remained comatose through this procedure but started to slowly respond to voice commands, corneal reflexes present and attempts to make spontaneous movements followed.
 
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Brand NameARROW
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key8068564
MDR Text Key127117037
Report Number8068564
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIPN038164
Device Catalogue NumberASK-42703-PMC-S1
Device Lot Number13F18G0533
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2018
Event Location Hospital
Date Report to Manufacturer11/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/14/2018 Patient Sequence Number: 1
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