MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 20 GA X 1-3/4"; CATHETER PERCUTANEOUS

Catalog Number RA-04020-SP

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: arterial line was placed second attempt.The wire did not pass smoothly.The wire was pulled out of the artery while the catheter remained in place.Ultrasound revealed catheter tip in posterior wall.Pulled the catheter back to center of lumen (a few millimeters) and the wire passed.When the user tried to pull the wire unit out of the white catheter, the unit would not deach (the red hub would not disengage from the white arterial catheter).The user decided to pull the whole unit (wire assembly, red hub, and white catheter together), the guidewire had unraveled to a thin thread.The user retracted the wire slowly until it was removed intact.The tip of the guidewire was visible.No patient harm was reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: arterial line was placed second attempt.The wire did not pass smoothly.The wire was pulled out of the artery while the catheter remained in place.Ultrasound revealed catheter tip in posterior wall.Pulled the catheter back to center of lumen (a few millimeters) and the wire passed.When the user tried to pull the wire unit out of the white catheter, the unit would not deach (the red hub would not disengage from the white arterial catheter).The user decided to pull the whole unit (wire assembly, red hub, and white catheter together), the guidewire had unraveled to a thin thread.The user retracted the wire slowly until it was removed intact.The tip of the guidewire was visible.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one arterial catheterization device for evaluation.Significant signs of use in the form of dried biomaterial were observed inside the device.Visual inspection of the device revealed the guide wire was separated near the distal end.The guide wire was returned stuck within both the cannula and the catheter.The distal weld was still present at the distal end.The device handle was also observed to be broken.Microscopic examination confirmed the damage.The distal weld appeared full and spherical.The guide wire was removed from the cannula and catheter to perform functional inspection (see below).Significant amounts of biomaterial were observed on the portions of the guide wire that were stuck inside the catheter.The guide wire core wire pieces measured 4 5/8" and 1/2", totaling 5 1/8", (b)(4).Therefore, no pieces of the core wire appear to be missing.The guide wire outer diameter measured 0.432mm, (b)(4).Functional inspection of the returned catheter and cannula was performed per the product ifu which states, "stabilize position of introducer needle and carefully advance guidewire into vessel using guidewire handle.When the reference mark on the clear feed tube coincides with the edge of the internal cylinder of the guidewire handle the tip of the guidewire is located at the needle tip." while withdrawing the returned guide wire from the catheter and cannula, the guide wire separated in additional locations.A lab inventory 0.018" guide wire was threaded through the returned needle cannula and catheter with no resistance.Based on the findings above, it cannot be confirmed whether the damage to the guide wire was caused by resistance encountered within the needle cannula during initial insertion, or whether it was caused by an accumulation of biomaterial within the cannula or catheter during use.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture.Warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel." the customer report of guide wire/catheter resistance was confirmed through complaint investigation of the returned sample.Visual i nspection revealed the guide wire was separated near the distal end.Significant amounts of dried biomaterial were observed inside the catheter and needle cannula.The guide wire met all relevant dimensional requirements, and a device history record review was per formed based on a potential lot identified from sales history with no relevant findings.Based on the condition of the returned sample and the available information, it could not be determined whether the damage to the guide wire was caused by the needle cannula during initial insertion, or by an accumulation of biomaterial inside the device during use.Based on these circumstances, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Type of Device: CATHETER PERCUTANEOUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16405818
• MDR Text Key: 310173156
• Report Number: 9680794-2023-00079
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

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 Number: RA-04020-SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/20/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED