MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-26702-E

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

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "patient in whom an ultrasound-guided central catheter is placed, left subclavian jugular via without complications, at the moment of removing the guide cannot be removed, it remains trapped, insists on its removal evidence that it's lost his memory at the end proximal, and it's unrolled, at the risk of staying inside the patient.It's tracked, presenting at the same time withdrawal of the guide and withdrawal of the vascular device (the guide is strongly adhered to the catheter)." no medical intervention was required.The device was removed and replaced.It was reported there was a delay in therapy without harm to the patient.

Event Description

The complaint is reported as: "patient in whom an ultrasound-guided central catheter is placed, left subclavian jugular via without complications, at the moment of removing the guide cannot be removed, it remains trapped, insists on its removal evidence that it's lost his memory at the end proximal, and it's unrolled, at the risk of staying inside the patient.It's tracked, presenting at the same time withdrawal of the guide and withdrawal of the vascular device (the guide is strongly adhered to the catheter)." no medical intervention was required.The device was removed and replaced.It was reported there was a delay in therapy without harm to the patient.

Manufacturer Narrative

(b)(4).The customer returned an opened cv-26702-e kit with a guide wire, and a 2-lumen catheter for evaluation.The guide wire was advanced through the catheter and was unraveled.The components showed evidence of use in the form of dried blood.The guide wire was removed from the catheter to be able to inspect it more carefully.Visual examination revealed the guide wire is unraveled from the proximal weld and is kinked/distorted in several locations along the body.The returned catheter show evidence of use and deformations corresponding with the locations of the kinks in the guide wire.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The exposed proximal core wire tip is tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.Microscopic examination of the catheter revealed one kink about midway through the catheter body.The major kink in the guide wire body was measured at 320 mm from the distal tip.The broken core wire measured 600 mm in length which is within the specification of 596 - 604 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 0.79 mm which is within the specification of 0.788-0.826 mm per guide wire product drawing.The kink in the catheter body measured at 117 mm from the distal tip.The catheter body length measured 217 mm which is within the specification of 207-227 mm per catheter product drawing.A lab inventory guide wire of the same diameter as that supplied in kit passed through the distal extension line and undamaged portions of the returned catheter body with minimal resistance.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." a manual tug test confirmed that the distal weld was intact.A device history record review was performed and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring wire guide and catheter simultaneously.The report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire and catheter met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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 11070:2014 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.Based on these circumstances, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14189430
• MDR Text Key: 289961552
• Report Number: 3006425876-2022-00341
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/27/2023
• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F21F0388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• 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