MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"; CATHETER INTRAVASCULAR THERAP

Catalog Number CDC-42703-P1A

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information obtained from maude report (mw5082351/mdr report key (b)(4)).The report does not have any additional information or contact information.

Event Description

According to the maude report (mw5082351/mdr report key (b)(4)) the md was attempting to place a triple lumen in a critical patient when the introducer wire made a 90-degree bend and could not be advanced (mdr# 9680794-2019-00026).A second triple lumen kit was opened and had a problem with this wire (mdr #9680794-2019-00027).The wire in the second kit was stripped.Both kits were unusable.A different product was used successfully.

Event Description

According to the maude report (mw5082351/mdr report key (b)(4)) the md was attempting to place a triple lumen in a critical patient when the introducer wire made a 90-degree bend and could not be advanced (mdr# 9680794-2019-00026).A second triple lumen kit was opened and had a problem with this wire (mdr #9680794-2019-00027).The wire in the second kit was stripped.Both kits were unusable.A different product was used successfully.

Manufacturer Narrative

(b)(4).Additional information was received and the customer reported that there was no injury to the patient.The customer returned a spring wire guide and lidstock for evaluation.The catheter involved with the complaint was not returned by the customer.Visual examination revealed that the guide wire was unraveled from the proximal end.The j-bend at the distal end of the guide wire was intact and had maintained its shape.Two kinks were also observed approximately in the middle of the guide wire.Microscopic examination revealed signs of use in the form of biological material.The distal weld appeared spherical and intact.The proximal weld was spherical but had separated from the core wire.Despite this, the weld was still attached to the coils.The guide wire diameter and length from the distal end to the proximal tip of the core wire were and were found to be within specification.The kinks in the guide wires measured 179mm and 282mm from the distal tip.A manual tug test was performed on the guide wire.The distal weld appeared secure in the guide wire assembly.A device history record review was performed with no relevant findings to suggest a manufacturing issue.The ifu provided with the kit warns the user, "do not apply excessive force in removing spring wire guide or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained, and further consultation requested".The ifu also informs, "maintain firm grip on spring-wire guide at all times." the report that the guide wire was unraveled was confirmed through examination of the returned sample.Visual examination revealed that the proximal weld had detached from the proximal tip of the core wire.Despite this, the weld was still attached to the coils.Two kinks were also observed approximately in the middle of the guide wire.The guide wire met all relevant dimensional requirements and a device history record review did not reveal any findings.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.Based on these circumstances and the sample returned, unintentional user error likely contributed to the unraveling of the guide wire; however, the probable cause of the guide wire kinking cannot be determined based on the customer description and without the catheter returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8281405
• MDR Text Key: 134333211
• Report Number: 9680794-2019-00027
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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 Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: CDC-42703-P1A
• Device Lot Number: 13F18D0506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 03/05/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1