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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 05/21/2017
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 pea (pulseless electrical activity) arrest during a kidney transplant in 2017. At that time, surgery was aborted. The troponin was elevated. The patient had an angiogram and coronary catheterization and stents placed. Patient again scheduled to receive renal transplant in 2019 and experienced subsequent pea arrest (captured in 9680794-2021-00502). Patient seen in anaphylaxis clinic and tested positive to chlorhexidine intradermal at 12 mm, and cholorhexidine skin prick test at 10 mm. The elevated troponin from both aborted kidney transplants felt to be consistent with an anaphylactic reaction. It was reported surgery aborted. Patient condition reported to be fine.
 
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Brand NameARROW CVC KIT
Type of DeviceCATHETER INTRAVASCULAR THERAPE
MDR Report Key12579243
MDR Text Key274827371
Report Number9680794-2021-00503
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
Treatment
NONE REPORTED
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