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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL LLC ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number ASK-45703-PGM3
Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "resistance met when removing straight end, which is when wire began to fray." no medical intervention required.It was reported there was "no harm from the wire".The patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).The report of a separated guide wire was confirmed through examination of the returned sample.The customer returned one defective guide wire for analysis.Signs-of-use were observed on the guide wire surface.It was noted that the guide wire was wrapped around itself upon receipt.Slight kinks were noted in this section of wrapping.Visual examination revealed the guide wire was unravelled from the distal end.Further analysis revealed that a section of the coil wire was completely severed from the rest of the assembly.The core wire appeared to be severed 3mm from the distal weld.This resulted in distal j-bend to be slightly misshapen.The guide wire met all functional and dimensional requirements during investigation testing.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 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 and the appearance of the damage, the damage seems consistent with that of an unintentional use error root cause; however, this could not be confirmed without the introducer needle also returned for analysis.Therefore, the root cause could not be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported "resistance met when removing straight end, which is when wire began to fray." no medical intervention required.It was reported there was "no harm from the wire".The patient's current condition is reported as "fine".
 
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Brand Name
ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN
Type of Device
CATHETER INTRAVASCULAR THERAPE
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18949600
MDR Text Key338243504
Report Number9680794-2024-00256
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10801902213768
UDI-Public10801902213768
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/27/2024
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 Catalogue NumberASK-45703-PGM3
Device Lot Number33F23F0185
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/27/2024
Initial Date FDA Received03/21/2024
Supplement Dates Manufacturer Received03/22/2024
Supplement Dates FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2023
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
NONE REPORTED; NONE REPORTED
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