MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI SET: 9 FR; INTRODUCER, CATHETER

Model Number IPN920646

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

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported there was resistance when removing the guidewire and dilator and the guidewire unravelled.The entire device including the guidewire was removed.There was no patient harm.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The customer returned a guidewire, sheath, and product lidstock for analysis.The guide wire was unraveled and showed no evidence of use.Visual examination revealed the guide wire is unraveled from the distal end and one major kink and multiple bends in the guide wire body.The distal end of the core wire is broken and protruding out of the coil wire.The distal j-bend is misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.Both welds appeared full and spherical.Visual analysis of the dilator could not be performed as the dilator was not returned.The major kink in the guide wire was measured at 194mm from the proximal tip.The broken core wire measured 602mm in length which is not within the specification limits of 450-458mm per guide wire product drawing.The outer diameter of the guide wire measured 0.790 which is not within the specification limit of 0.838 - 0.877mm per guide wire product drawing.This indicates that either the incorrect guide wire was returned, or the incorrect product code was reported by the customer.Functional i nspection 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 and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user "do not apply excessive force in placing or removing guidewire, dilator, or sheath.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to 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 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.However, the outer diameter and length of the returned guide wire did not match the guide wire supplied in the reported kit, indicating that either the incorrect guide wire was returned, or the incorrect product code was reported by the customer.The probable cause of guide wire damage could not be determined based on the dimensional discrepancy between the customer reported kit and the returned sample and without the dilator returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported there was resistance when removing the guidewire and dilator and the guidewire unravelled.The entire device including the guidewire was removed.There was no patient harm.The patient's condition is reported as fine.

• Brand Name: ARROW PSI SET: 9 FR
• Type of Device: INTRODUCER, CATHETER
• 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: 14837134
• MDR Text Key: 295967169
• Report Number: 9680794-2022-00403
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10801902196351
• UDI-Public: 10801902196351
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K780532
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN920646
• Device Catalogue Number: SI-09903-E
• Device Lot Number: 14F21J0286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• 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
• Treatment: 9FR SWAN SHEATH INTRODUCER (TELEFLEX); 9FR SWAN SHEATH INTRODUCER (TELEFLEX)