MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 12CM; CATHETER PERCUTANEOUS

Catalog Number SAC-01218-PBX

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "a senior resuscitation doctor faced difficulties on (b)(6) 2022, with a femoral arterial catheter.During the insertion the guide of the arterial catheter got stuck in the subcutaneous tissue, at the level of the left inguinal fold.The guide was removed after tissue dissection and 2 stitches.".

Event Description

It was reported that: "a senior resuscitation doctor faced difficulties on (b)(6) 2022, with a femoral arterial catheter.During the insertion the guide of the arterial catheter got stuck in the subcutaneous tissue, at the level of the left inguinal fold.The guide was removed after tissue dissection and 2 stitches.".

Manufacturer Narrative

(b)(4).The customer returned one guide wire for evaluation.The catheter was not returned.Visual examination revealed the core wire was separated 35 mm from the distal weld and has multiple kinks in the guide wire body.Both ends of the core wire are protruding out of the coil wire.The distal j-bend is misshapen.Microscopic examination of the guide wire confirmed the core wire was broken and that both welds were present.Visual inspection of the catheter could not be performed as the catheter was not returned.The two sections of broken core wire measured 302 mm and 35 mm in length, totaling 337 mm, which is within the specification of 331-339.8 mm per guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.620 mm which is within the outer diameter specification of 0.610-0.635 mm per guide wire product drawing.Dimensional inspection of the catheter could not be performed as the catheter was not returned.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product warns the user, "if resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire.".The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken approximately 35 mm from the distal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of at least 2.0 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 1.1 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, unintentional use error likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 12CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16011277
• MDR Text Key: 306071182
• Report Number: 3006425876-2022-01110
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAC-01218-PBX
• Device Lot Number: 71F22C1605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• 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
• Patient Outcome(s): Required Intervention