MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SPRING WIRE GUIDE COMPONENT; CATHETER INTRAVASCULAR THERAPE

Model Number IPN036230

Device Problem Unraveled Material (1664)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "guide wire has unraveled when the guide wire is pulled back." no medical intervention was required.No patient harm.The patient's condition is reported as "stable".

Manufacturer Narrative

(b)(4).The customer returned a single guide wire and the product lidstock for evaluation.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire was unraveled from the proximal weld and had multiple kinks in the guide wire body.The proximal end of the core wire was broken and protruding out of the coil wire.The distal j-bend was misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire.The exposed proximal core wire tip was tapered and discolored at the point of separation.Both welds appeared full and spherical.The major kinks in the guide wire body were measured at 288mm, 337mm, and 468mm from the distal tip.The broken core wire measured 685 mm in length which is within the specification of 679 - 687 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 0.847 mm which is within the specification of 0.838 - 0.877 mm per guide wire product drawing.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 distal weld was intact.A device history record review was performed on the guide wire 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 met all functional and 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.

Event Description

It was reported that "guide wire has unraveled when the guide wire is pulled back." no medical intervention was required.No patient harm.The patient's condition is reported as "stable".

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12707840
• MDR Text Key: 278824976
• Report Number: 9680794-2021-00561
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902122534
• UDI-Public: 10801902122534
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/12/2021

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 Model Number: IPN036230
• Device Catalogue Number: AW-14735
• Device Lot Number: 14F20G0171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• 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