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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL INC. ARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CDC-22123-1A
Device Problems Failure to Advance (2524); Material Deformation (2976)
Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2020
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: used to complete insertion of the central line- two 12 fr guide wires kinked or bent while introducing wire.A third package was opened, this time an 8.5 fr and the procedure was completed.(b)(4).A medwatch number is not documented on the user facility's medwatch report.Additional information: the risk manager reports that the patient had an iv in place upon admission to the er department.The risk manager reports that the device was not a factor in the patient's death.The patient was involved in a major vehicle accident and sustained multiple severe injuries.The patient arrived in the er department "coding".Note: additional mdr (9680794-2020-00067) will be submitted to reflect the second device with an alleged issue.
 
Event Description
According to the medwatch "during code trauma resuscitation a central line was being placed.During the process, three packages had to be opened to utilize a guide wire to facilitate placement of the central line.Guide wires kinked or bent during the placement, which would not allow the catheter to be passed over the wire.No injury to patient".
 
Manufacturer Narrative
Continuation of d11: used to complete insertion of the central line- two 12 fr guide wires kinked or bent while introducing wire.A third package was opened, this time an 8.5 fr and the procedure was completed.(b)(4) the customer returned one guide wire (swg) for evaluation.The guide wire contained obvious signs of use in the form of biological material.Visual analysis revealed several kinks/bends along the guide wire body as well as two prominent kinks.The distal j-bend also appeared slightly misshapen.Microscopic examination confirmed the distal and proximal welds were fully formed and intact.The prominent kinks/bends in the guide wire were located 275 and 299 mm from the proximal end.The total length of the guide wire measured to be 602 mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the guide wire measured to be 0.845 mm which is within specifications of 0.838-0.877 mm per product drawing.No dimensional issues were found.The returned guide wire was passed through a lab inventory ars/introducer needle assembly.Significant resistance was encountered at the kinks; however, the undamaged portions were able to advance with minimal resistance.A manual tug test confirmed that the proximal and distal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed numerous bends along the body of the guide wire.The guide wire met all relevant dimensional requirements and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
According to the medwatch "during code trauma resuscitation a central line was being placed.During the process, three packages had to be opened to utilize a guide wire to facilitate placement of the central line.Guide wires kinked or bent during the placement, which would not allow the catheter to be passed over the wire.No injury to patient.".
 
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Brand Name
ARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9735329
MDR Text Key180305895
Report Number9680794-2020-00066
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Catalogue NumberCDC-22123-1A
Device Lot Number13F19H0118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Date Manufacturer Received03/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ARROWGARD BLUE PSI KIT CATH-GARD CDC-29803-1A WAS; ARROWGARD BLUE PSI KIT CATH-GARD CDC-29803-1A WAS; ARROWGARD BLUE PSI KIT CATH-GARD CDC-29803-1A WAS
Patient Outcome(s) Death; Other;
Patient Age62 YR
Patient Weight170
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