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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CV-25703-E
Device Problems Unraveled Material (1664); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2024
Event Type  malfunction  
Event Description
It was reported "during the passage of the central venous catheter, the guide wire disintegrated upon attempted removal." the cather was successfully removed and upon removal the guide wire was noted to be bent.No medical intervention required.The patient's current condition is reported as "fine".
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The customer report of an unravelled guide wire was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns 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." a device history record review was performed, and no relevant findings were identified.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.Without the sample to evaluate, the probable root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported "during the passage of the central venous catheter, the guide wire disintegrated upon attempted removal." the catheter was successfully removed and upon removal the guide wire was noted to be bent.No medical intervention required.The patient's current condition is reported as "fine".
 
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Brand Name
ARROW CVC SET: 3-LUMEN 7FR X 20CM
Type of Device
CATHETER,INTRAVASCULAR,THERAP
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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18740786
MDR Text Key335773621
Report Number3006425876-2024-00150
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/31/2024
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 NumberCV-25703-E
Device Lot Number71F22H2052
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/31/2024
Initial Date FDA Received02/20/2024
Supplement Dates Manufacturer Received03/21/2024
Supplement Dates FDA Received03/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2022
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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