MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24703-E

Device Problems Entrapment of Device (1212); Unraveled Material (1664)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/26/2022

Event Type  Injury  

Event Description

The customer complaint is reported as: "the customer described that swg (spring wire guide) was unable to be removed after insertion.So, the doctor used the second swg which had the same situation as the first one.Finally, he used the third one, swg still had the same issue and unraveled.Eventually, the doctor cooperated with cardiac surgery doctor to remove the swg by surgery." additional information received 15sep2022 reports: the first and second wires were only kinking and were able to be removed.No surgery was required.The third guidewire was stuck in the patient and required surgery to remove.The patient's current condition is reported as fine.

Manufacturer Narrative

(b)(4).Associated complaints in mdr #s: 3006425876-2022-00849; 3006425876-2022-00850.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided five photos for analysis.Two images showed a kinked guide wire while inside the tubing assembly.One image showed an unraveled/separated guide wire while still inside the patient.The final two images show a separated guide wire.Signs of use were observed on the guide wires in all five images.Visual analysis could not be accurately performed on the guide wire involved with this complaint as it was not returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.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 of a separated guide wire was confirmed through analysis of the customer supplied photos.Analysis of the photos showed an unraveled/separated guide wire while inside and removed from the patient; however, a full visual analysis could not be performed to confirm.A device history record review was performed, and no relevant findings were identified.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.Despite this, a full visual/dimensional/functional analysis could not be performed on the guide wire as it was not returned for analysis.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer complaint is reported as: "the customer described that swg (spring wire guide) was unable to be removed after insertion.So, the doctor used the second swg which had the same situation as the first one.Finally, he used the third one, swg still had the same issue and unraveled.Eventually, the doctor cooperated with cardiac surgery doctor to remove the swg by surgery.".Additional information received 15sep2022 reports: the first and second wires were only kinking and were able to be removed.No surgery was required.The third guidewire was stuck in the patient and required surgery to remove.The patient's current condition is reported as fine.Associated complaints in mdr #s: 3006425876-2022-00849; 3006425876-2022-00850.

Manufacturer Narrative

(b)(4).The customer returned one guide wire assembly and a lidstock for analysis.Signs of use in the form of biological material were observed on the guide wire.Visual analysis revealed that the guide wire was unraveled from the distal end.In addition to the unraveling, further analysis also revealed that the core and coils wires had become separated.Microscopic examination confirmed the damage and revealed that the core wire had separated approximately 21mm from the distal weld.The damage resulted in the distal j-bend to be misshapen.Several locations of offset coils were also observed.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The point of separation on the core wire measured 21mm from the distal weld.The total length of the separated portions of the core wire measured 685mm, which is within the specification limits of 679mm-687mm per the guide wire product drawing.The guide wire outer diameter measured.812mm, which is within the specification limits of.788mm-.826mm per the guide wire product drawing.While performing dimensional analysis, the coil wire became further separated.The functional portion of the guide wire was inserted through a lab inventory arrow raulerson syringe (ars)/introducer needle subassembly.The guide wire was able to pass with little to no difficulty.Performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the proximal and distal welds were secure and intact.R & d was contacted as part of this complaint investigation.Based on the analysis of the customer supplied and investigation images, they confirmed that the observed failure mode is consistent with damage due to withdrawing the guide wire back through the needle cannula/bevel during insertion.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.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 ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report that the guide wire was unraveled was confirmed through examination of the returned sample.The core wire was unraveled/ separated towards the distal end; however, the point of separation on the core wire measured 21mm from the distal weld.Confirmation from r & d revealed that the observed failure mode appears consistent with undue force applied during insertion.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant 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.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

The customer complaint is reported as: "the customer described that swg (spring wire guide) was unable to be removed after insertion.So, the doctor used the second swg which had the same situation as the first one.Finally, he used the third one, swg still had the same issue and unraveled.Eventually, the doctor cooperated with cardiac surgery doctor to remove the swg by surgery." additional information received (b)(6).2022 reports: the first and second wires were only kinking and were able to be removed.No surgery was required.The thrid guidewire was stuck in the patient and required surgery to remove.The patient's current condition is reported as fine.Associated complaints in mdr #s: 3006425876-2022-00849; 3006425876-2022-00850; 3006425876-2022-00848.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 15595496
• MDR Text Key: 301648125
• Report Number: 3006425876-2022-00848
• 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,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/27/2023
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F21K0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 10/12/2022; 11/08/2022
• Supplement Dates FDA Received: 10/17/2022; 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• 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
• Patient Outcome(s): Required Intervention