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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25703-E
Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/16/2023
Event Type  malfunction  
Event Description
It was reported that "swg hard to advance.The issue occurred on 4 different patients.There was no reported patient harm." associated complaints 3006425876-2024-00259, 3006425876-2024-00261, 3006425876-2024-00264 and 3006425876-2024-00260.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "swg hard to advance.The issue occurred on 4 different patients.There was no reported patient harm." associated complaints 3006425876-2024-00259, 3006425876-2024-00261, 3006425876-2024-00264 and 3006425876-2024-00260.
 
Manufacturer Narrative
Qn#(b)(4) the customer provided one image showing multiple guide wire assemblies.Kinking on at least one guide wire is visible.The customer also returned one guide wire assembly for analysis.The straightener tubing and cap were not included.Signs of use in the form of biological material were observed on the guide wire surface.Visual analysis revealed one kink towards the distal end.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.No obvious defects were noted with the j-bend nor the guide wire tubing.After failing dimensional analysis, the returned sample was compared with the guide wire product drawing.The markings on the returned sample do not match the markings on the product drawing.The kink on the guide wire measured from the proximal weld.The guide wire total length measured 685mm, which is not within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured 0.830mm, which is not within the specification limits of 0.788mm-0.826mm per the guide wire product drawing.The discrepancy with the guide wire length and outer diameter measuring out of specification indicates that either the incorrect guide wire was returned , or the incorrect finished good was reported.The returned guide wire was inserted through a lab inventory arrow raulerson syringe (ars)/introducer needle subassembly.Little to no resistance was encountered as the guide wire passed completely through the assembly.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 of the returned sample.The guide wire was kinked towards the distal end; however, the guide wire length and outer diameter did not meet the specification requirements.It is unknown if the incorrect guide wire was returned or if the incorrect finished good was reported.A device history record review was performed on the reported finished good with no relevant findings.Based on the customer report and the kinking observed on the returned sample, the failure appears consistent with damage due to unintentional use error; however, due to the dimensional discrepancies and the fact that the guide wire markings do not match what is shown in the product drawing , the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 20 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 Key18796707
MDR Text Key336429951
Report Number3006425876-2024-00260
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
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 Catalogue NumberCS-25703-E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2024
Supplement Dates Manufacturer Received03/14/2024
Supplement Dates FDA Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
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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