MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-22123-F

Device Problem Unraveled Material (1664)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported the "spring" of the spring wire guide was loose during patient use.No patient harm reported.A new guidewire was used.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one guide wire within its advancer tubing for evaluation.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire was unraveled from the distal weld and had multiple kinks in the guide wire body.The distal end of the core wire is broken and protruding out of the coil wire.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.The exposed proximal core wire tip was rounded, pinched and discolored at the point of separation.Both welds appeared full and spherical.The major kinks in the guide wire body were measured at 250 mm and 309mm from the proximal 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 0.861 mm which is within the outer diameter 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 proximal 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 the kit describes suggested techniques to minimize the likelihood of guide wire breakage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.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.Based on these circumstances, unintentional use error likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported the "spring" of the spring wire guide was loose during patient use.No patient harm reported.A new guidewire was used.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12675283
• MDR Text Key: 277727932
• Report Number: 3006425876-2021-00975
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/25/2022
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F21B1251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• 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