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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-15123-F
Device Problem Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported there was a third incident with the spring wire guide during patient use.Additional information regarding event details and device issue was requested multiple times, but was not available at the time of this report.Prior events reported by customer for guidewire unraveling (captured in 3006425876-2021-00227) and guidewire breaking captured in 3006425876-2021-00228).
 
Event Description
Customer reported there was a third incident with the spring wire guide during patient use.Additional information regarding event details and device issue was requested multiple times, but was not available at the time of this report.Prior events reported by customer for guidewire unraveling (captured in 3006425876-2021-00227) and guidewire breaking captured in 3006425876-2021-00228).
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one spring wire guide (swg) and lidstock for evaluation.Visual inspection of the swg revealed the swg was unraveled and had multiple bends in its body.Microscopic examination of the swg confirmed that the distal weld separated from the core wire but was still attached to the coil wire.No defects were observed with the proximal weld.The kinks in the guide wire measured 25mm, 240mm, 330mm, 370mm, 458mm, and 520mm from the proximal weld.The guide wire total length measured 680mm, which is within the specification limits of 678mm-688mm per the guide wire graphic.The guide wire outer diameter measured.845mm, which is within the specification limits of.838mm-.877mm per the guide wire graphic.Functional inspection was performed to recreate the product's intended use.The ifu provided with this kit states: "advance spring-wire guide into the syringe approximately 10 cm until it passes through syringe valves".The guide wire was inserted through a lab inventory ars and introducer needle.Resistance was observed at the damaged portions of the guidewire.A manual tug test confirmed the proximal weld was fully intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user "warning: do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report that the guide wire was unraveled was confirmed through examination of the returned sample.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.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 (b)(4) 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 possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.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.
 
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Brand Name
ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11870432
MDR Text Key252201022
Report Number3006425876-2021-00502
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K970864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCS-15123-F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Date Manufacturer Received06/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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