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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PEDIATRIC JUGULAR KIT: 20GA X 5"; CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW PEDIATRIC JUGULAR KIT: 20GA X 5"; CATHETER PERCUTANEOUS Back to Search Results
Catalog Number AK-04150-E-S
Device Problem Material Deformation (2976)
Patient Problems Death (1802); No Information (3190)
Event Date 07/17/2019
Event Type  Death  
Manufacturer Narrative
(b)(4).Customer contacted to obtain additional information regarding the event.No additional information received at the time of this report.
 
Event Description
It was reported that the catheter kinked during insertion by physician.Device was used in 3 different attempts and delayed case for patient.The reported defect was detected during use.There is a patient death reported.The customer was not clear if the reported issue caused/contributed/factored in the death of the patient.Therapy was reported to be delayed/interrupted.
 
Manufacturer Narrative
(b)(4).The customer returned a guide wire, single lumen catheter and the product lidstock for evaluation.The guide wire was returned partially advanced through the catheter with a portion protruding out the catheter distal tip and a portion protruding out the proximal catheter hub.The guide wire was not able to move freely within the catheter and evidence of use was observed on the components.The guide wire was observed to have a several kinks/offset coils in the distal portion protruding out the catheter tip.Two kinks/bends were also observed on the proximal portion of the guide wire.The distal j-bend was severely misshapen but intact.Significant dried blood was observed within the catheter hub where the guide wire was entering the hub.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.No damage or defects were observed with the returned catheter.The major kinks in the guide wire were located 19 and 23 mm from the distal tip as well as 11 and 45 mm from the proximal tip.The outer diameter of the guide wire measured 0.624 mm which is within the specification of 0.610-0.635 mm per guide wire product drawing.The guide wire overall length could not be accurately measured due to the damage.The catheter tip inner diameter measured 0.026" which is within the specification of 0.025"-0.027" per catheter product drawing.The catheter body length measured 4.75" which is within the specification of 4.375"-4.875" per catheter product drawing.The guide wire was able to be forcibly removed from the catheter with further damage to either component.Significant dried blood was observed on the portion of the guide wire body that had been contained within the catheter body.After flushing the catheter body of dried blood, the catheter was functionally tested using lab components.An undamaged lab inventory guide wire of the same diameter as the returned guide wire passed through the catheter hub and catheter body of the returned catheter with minimal resistance.This indicates that the resistance between the returned catheter and guide wire was due to the dried blood observed.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the catheter and guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire kinked during use was confirmed through examination of the returned sample.A guide wire and catheter were returned with the guide wire returned partially advanced through the catheter.The distal portion of the guide wire that was protruding out of the catheter distal tip was severely kinked and deformed.The guide wire was returned stuck within the catheter but was able to be forcibly removed without further damage.After being rinsed of dried blood, resistance was no longer met while functionally testing the two components indicating the resistance was due to the dried blood observed.The returned guide wire and catheter met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported that the catheter kinked during insertion by physician.Device was used in 3 different attempts and delayed case for patient.The reported defect was detected during use.There is a patient death reported.The customer was not clear if the reported issue caused/contributed/factored in the death of the patient.Therapy was reported to be delayed/interrupted.
 
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Brand Name
ARROW PEDIATRIC JUGULAR KIT: 20GA X 5"
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8950663
MDR Text Key156132557
Report Number9680794-2019-00343
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K810962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2023
Device Catalogue NumberAK-04150-E-S
Device Lot Number13F19D0532
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2019
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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