MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-25802-E

Device Problems Difficult to Remove (1528); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the procedure was successful until catheter insertion.When the physician tried to withdraw the wire , it stuck inside the patient's body.The patient was sent to department of anesthesiology to perform an emergency c-arm x-ray to check the wire.The wire was found forming two knots in the vein.The physician slowly withdrew the first knot with the help of the x-ray.The second knot was stuck tightly inside.The surgeon had to make a small incision (less than 1cm) on the skin to take it out.Another kit was opened to perform the procedure again.

Event Description

The customer reports that the procedure was successful until catheter insertion.When the physician tried to withdraw the wire , it stuck inside the patient's body.The patient was sent to department of anesthesiology to perform an emergency c-arm x-ray to check the wire.The wire was found forming two knots in the vein.The physician slowly withdrew the first knot with the help of the x-ray.The second knot was stuck tightly inside.The surgeon had to make a small incision(<1cm) on the skin to take it out.Another kit was opened to perform the procedure again.

Manufacturer Narrative

(b)(4).The customer returned one guide wire (swg) for evaluation.The guide wire contained obvious signs of use in the form of biological material.Many regions of coagulated/clotted blood were observed.Visual examination of the wire revealed numerous kinks and bends.The guide wire also contained multiple sharp kinks.The j-tip appeared slightly deformed.Both the proximal and distal welds of the wire were fully spherical and intact.The guide wire contained the most prominent kinks 145-160 mm and 365 mm from the proximal tip.The total length of the guide wire measured to be 601 mm which is within specifications of 596-604 mm per product drawing.The outer diameter of the guide wire measured to be 0.788 mm which is within specifications of 0.788-0.826 mm per product drawing.No dimensional issues were identified.The undamaged portions of the returned swg were able to advance through a lab inventory introducer needle and catheter.Significant resistance was encountered at the kinks/bends.A manual tug test confirmed both the distal and proximal welds of the guide wire were fully intact.A device history record review was performed on the guide wire with no relevant findings.The instructions-for-use provided with this kit warns the user, "do not apply undue force on guidewire to reduce risk of possible breakage." the ifu also instructs the user, "if resistance is encountered, withdraw catheter relative to guidewire about 2-3 cm and attempt to remove guidewire.If resistance is again encountered, remove guidewire and catheter simultaneously." the customer report of difficulty removing the guide wire was confirmed by complaint investigation of the returned sample.The returned guide wire contained numerous sharp kinks, bends, and clotted biological material, making the guide wire difficult to advance and remove.The device passed all relevant dimensional and functional inspection, and a device history record review was performed with no relevant findings.Based on the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• 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 Key: 9910512
• MDR Text Key: 186729993
• Report Number: 3006425876-2020-00280
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2021
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F19H0838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention