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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP
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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CS-25802-E
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the spring wire guide was stuck in the patient.The entire spring wire guide was removed from the patient.No medical intervention was required.No patient injury or complication.The patient's condition is reported as fine.
 
Event Description
Customer reported the spring wire guide was stuck in the patient.The entire spring wire guide was removed from the patient.No medical intervention was required.No patient injury or complication.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer returned one opened kit containing a guide wire assembly, introducer needle, and arrow raulerson syringe (ars) for analysis.Signs of use in the form of biological material was observed on the guide wire and introducer needle.The guide wire was returned inserted through the introducer needle/ars subassembly.Visual examination revealed one kink at the proximal end of the ars plunger.The guide wire was unable to be removed from the ars/needle.The guide wire contained one kink/bend 330 mm from the proximal end.The total length of the returned guide wire measured to be 604 mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the returned guide wire measured to be 0.795 mm which is within specifications of 0.788-0.826 mm per product drawing.The inner diameter of the returned needle cannula could not be measured as the guide wire could not be removed from the needle.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was unable to advance or retract from the returned ars/needle assembly.The resistance was likely caused by the significant amount of biological material and damage to the guidewire.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 this kit warns the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire contained one kink/bend.This in combination with the dried biological material likely caused the resistance.The guide wire met all relevant dimensional requirements and a device history record review was performed with no relevant findings.Based on the customer report and the sample received unintentional user error likely 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: 2-LUMEN 8 FR X 20 CM
Type of Device
CATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key11557957
MDR Text Key242682949
Report Number3006425876-2021-00257
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 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date01/21/2022
Device Catalogue NumberCS-25802-E
Device Lot Number71F20B0915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2021
Date Manufacturer Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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