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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 Problem Unraveled Material (1664)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2024
Event Type  malfunction  
Event Description
It was reported that: " during the procedure according to ifu, the md found the guide wire to be faulty.So the md opened up the new kit to finish the procedure.There was no reported patient harm or consequence.The returned device was noted to be kinked.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly and one introducer needle for evaluation.The guide wire was returned partially advanced through the needle and was unraveled.Visual inspection revealed the guide wire was unraveled from the distal end.No obvious kinking was observed in the guide wire.Microscopic examination confirmed the damage, and revealed the core wire separation occurred adjacent to the distal weld.Both welds were present and appeared full and spherical.The broken core wire measured 599mm, totaling 353mm, which is within the specifications of 596-604mm per product drawing.The guide wire outer diameter measured 0.79mm which is within the specifications of 0.788-0.826mm per product drawing.Dimensional inspection of the needle could not be accurately performed as the unraveled portion of the guide wire was stuck inside the cannula and could not be removed.Functional inspection could not be performed since the unraveled portion of the guide wire was stuck inside the needle cannula and could not be removed.A manual tug test confirmed the proximal weld was intact.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with the kit warns the user , "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld and the components were returned with the guide wire partially advanced through the introducer needle.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the difficult advancing the guide wire.Based on these circumstances, 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: " during the procedure according to ifu, the md found the guide wire to be faulty.So the md opened up the new kit to finish the procedure.There was no reported patient harm or consequence.The returned device was noted to be kinked.
 
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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 Key18805615
MDR Text Key336625077
Report Number3006425876-2024-00274
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCS-22702-E
Device Lot Number71F23F1095
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/28/2024
Initial Date FDA Received02/29/2024
Supplement Dates Manufacturer Received03/01/2024
Supplement Dates FDA Received03/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED.; NOT REPORTED.
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