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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE
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ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-25703-E
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The complaint is reported as: "md was performing the procedure according to ifu.Md found that the j-tip guide wire was bent and stretched when pushed with a little force for insert.So md judged as defective product and finished the procedure using new product".It was reported "the j-tip guide wire sags".No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned a guide wire assembly for evaluation.No definite signs-of-use were observed.The guide wire was observed to have one kink towards the distal end of the body.The distal j-bend appeared to be intact.Microscopic examination confirmed the kink on the guide wire body.Both welds were present and were observed to be full and spherical.The kink on the guide wire measured 62mm from the distal tip.The overall length of the guide wire measured 601 mm which is within the specification of 596mm-604mm per guide wire product drawing.The outer diameter of the guide wire measured 0.790 mm which is within the specification of 0.788mm-0.826mm per guide wire product drawing.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire per ifu which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle.Advancement of guidewire through arrow raulerson syringe may require a gentle rotating motion.Thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".The guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.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 kinked during use was confirmed through examination of the returned sample.The guide wire contained two kinks near the distal end.The returned guide wire 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
The complaint is reported as: "md was performing the procedure according to ifu.Md found that the j-tip guide wire was bent and stretched when pushed with a little force for insert.So md judged as defective product and finished the procedure using new product".It was reported "the j-tip guide wire sags".No patient harm reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
MDR Report Key12253443
MDR Text Key264327104
Report Number3006425876-2021-00712
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 company representative,distri
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/07/2022
Device Catalogue NumberCS-25703-E
Device Lot Number71F20L2026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/23/2020
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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