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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE

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ARROW CVC KIT CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Biocompatibility (2886)
Patient Problem Anaphylactic Shock (1703)
Event Date 01/15/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical devices: ne (20 mg iv), propofol (250 mg iv), and rocuronium (80 mg iv)qn#: (b)(4).
 
Event Description
Through a review of records the customer reports a suspected allergic reaction to an arrow catheter. The following is reported: "admitted to hospital (b)(6) 2019, in order to undergo transcatheter aortic valve implantation for severe aortic stenosis. Induced around 8:00 in the morning with fentanyl (250 mcg iv), midazolam (1 mg iv), ketamine (20 mg iv), propofol (250 mg iv), and rocuronium (80 mg iv). We believe following the induction that a central line was placed, which was coated with chlorhexidine. Approximately 5 minutes after the patient was induced, his blood pressure dropped precipitously from 170/60 to 60/10. Tachycardiac up to the 140s. There was no rash or urticaria present at this time. The patient was given epinephrine boluses, a total of 3 mg iv push doses. Blood pressure was nonresponsive and dropped as low as 50/10. At this time, an epinephrine infusion was started as well as phenylephrine. The patient apparently received cpr briefly. Around 8:15, there was a rise in peak inspiratory pressure up to 37 cm of water, as well as increasing end-tidal co2 and an audible wheeze. The patient was treated as anaphylaxis with diphenhydramine 50 mg iv and hy drocorisone 100 mg iv. Blood pressure eventually stabilized around 8:45 on an epinephrine infustion. In the operating room, an x-ray was done which ruled out a pneumothorax, and a tee was also completed which showed normal biventricular contraction and hyperdynamic motion. A tryptase level was drawn at that time, which was elevated at 30. 2. " patient condition reported to be fine. The patient was transferred to the icu following this event, and the procedure was performed 2 days later with a central venous line without chlorhexidine and alternate anesthetic agents. There were no complications with this procedure, and the patient went home feeling well.
 
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Brand NameARROW CVC KIT
Type of DeviceCATHETER INTRAVASCULAR THERAPE
MDR Report Key12578463
MDR Text Key274910873
Report Number9680794-2021-00501
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberVASCULAR UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2021
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: 10/05/2021 Patient Sequence Number: 1
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