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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-22702-E
Device Problems Material Separation (1562); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported the physician found the guidewire body broken (kinked) during use.A new kit was opened to finish the procedure.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one portion of a separated guide wire and one opened representative kit for evaluation.Visual inspection of the separated guide wire portion confirmed the separation.The guide wire contained one kink near the separated end.Microscopic examination confirmed the kink.The proximal weld was present and appeared full and spherical.Visual inspection of the representative guide wire revealed no obvious defects or anomalies.The kink in the guide wire was located 29mm from the proximal weld.The separated guide wire portion length measured 39mm.This is not within the specified length of 596-604mm per guide wire product drawing.This indicates the rest of the guide wire broke off and was not returned.The guide wire outer diameter measured 0.615mm which is not within the specifications of 0.788-0.826mm per guide wire product drawing.This indicates that either the incorrect guide wire was returned, or the incorrect part number was reported in the complaint.The representative guide wire length measured 602mm which is within the specification of 596-604mm per guide wire product drawing.The representative guide wire outer diameter measured 0.801mm which is within the specifications of 0.788-0.826mm per guide wire product drawing.A manual tug test confirmed the proximal weld was still attached to the core wire.A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guide wire separated was confirmed through examination of the returned sample.No manufacturing defects were found during this investigation.The guide wire did not meet relevant dimensional requirements, therefore, the customer either returned the incorrect guide wire or reported the incorrect part number.Arrow guide wires of the returned guide wire's size are designed and manufactured to withstand a tensile force of 2.0 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 1.1 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on the discrepancy between the returned guide wire and the reported part number, the root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported the physician found the guidewire body broken (kinked) during use.A new kit was opened to finish the procedure.No patient harm reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW CVC SET: 2-LUMEN 7 FR X 16 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key14738618
MDR Text Key295151100
Report Number3006425876-2022-00554
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2023
Device Catalogue NumberCS-22702-E
Device Lot Number71F21D1117
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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