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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 04/15/2019
Event Type  Injury  
Manufacturer Narrative
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: patient with prior pea (pulseless electrical activity) arrest in 2017 during a kidney transplant (captured in 9680794-2021-00503). In (b)(6) 2019, patient was again scheduled to receive a renal transplant from a deceased donor. Shortly after induction of anesthesia, he developed severe hypotension and had a subsequent pea arrest. The kidney transplant was once again aborted. Again elevated troponin. A coronary angiogram, showed the previously placed lad stent, was widely patent. There was mild to moderate distal left circumflex disease, but this did not explain his cardiac arrest. Patient was again discharged without a diagnosis. On review on the patient in the anaphylaxis clinic. Patient states that when exposed to chlorhexidine on skin, will develop pruritus and subsequently hives. Patient routinely will tell his dialysis nurses to clean his fistula with alcohol or saline. Going back through his history, he had an acute reaction to chlorhexidine while getting dialysis on (b)(6) 2018. At that time, the pt age was (b)(6). In testing in the allergy clinic, tested to latex, cefazolin, propofol, lidocaine, and cisatracurium where negative for all these substances. He tested positive to chlorhexidine intradermal at 12 mm, and chlorhexidine skin prick test at 10 mm. Appropriate histamine and saline controls. The elevated troponin from both aborted kidney transplants is felt to be consistent with an anaphylactic reaction. It was reported surgery was aborted. Patient condition reported to be fine.
 
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Brand NameARROW CVC KIT
Type of DeviceCATHETER INTRAVASCULAR THERAPE
MDR Report Key12578922
MDR Text Key276651727
Report Number9680794-2021-00502
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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