MAUDE Adverse Event Report: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problem Unraveled Material (1664)

Patient Problems Laceration(s) (1946); Insufficient Information (4580)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported the physician tried to insert the spring wire guide but failed.The third attempt was successful.

Event Description

It was reported the physician tried to insert the spring wire guide but failed.The third attempt was successful.No patient harm reported.Two mdrs were submitted for these events: 3006425876-2021-00926 - 1st event; 3006425876-2021-00925 - 2nd event.Additional information was received from the customer indicating that in the second event, the "wire was broken and the sharp edge injured the physician's hand." it was also reported that "the physician went tested for hiv and hepatitis, and both were negative.".

Manufacturer Narrative

Qn#(b)(4).The customer returned one, 2-lumen catheter, guide wire, and a lidstock for analysis.Signs-of-use in the form of biological material was observed inside the extension lines.The guide wire was returned partially inserted through the catheter body.Visual analysis revealed that the guide wire was severely unraveled towards the proximal end.Two major kinks were also observed.Additionally, the distal j-bend was misshapen.Microscopic examination confirmed that the core wire had separated directly adjacent to the proximal weld.Despite this, the proximal weld was still attached to the coil wire.Additionally, the proximal and distal welds were spherical and appeared normal.The major kinks in the guide wire measured 225mm and 285mm from the distal weld.The guide wire total length from the distal weld to the point of separation measured 600mm which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.812mm which is within the specification limits of.788mm-.826mm per the guide wire graphic.The catheter body length from the juncture hub to the distal tip measured 215mm which is within the specification limits of 207mm-227mm per the catheter graphic.The catheter body outer diameter measured 2.364mm which is within the specification limits of 2.360mm-2.460mm per the catheter extrusion graphic.A lab inventory guide wire with a diameter of.032" was passed through the returned catheter.Little to no resistance was observed.Performed per ifu statement "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".A manual tug test confirmed that the distal weld was secure and intact.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 report of an unraveled guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was severely unraveled towards the proximal end.Two major kinks were also observed across the guide wire body.The guide wire and the catheter met all relevant functional and dimensional requirements, and a device history record review did not reveal any 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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section f.10.-health effect clinical code corrected to 1946 section f.10.-health effect impact code corrected to 2199 section h.6.-health effect clinical code corrected to 1946 section h.6.-health effect impact code corrected to 2199.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• MDR Report Key: 12502447
• MDR Text Key: 272433539
• Report Number: 3006425876-2021-00925
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

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 Operator: Health Professional
• Device Expiration Date: 03/30/2022
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F20F0774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 10/13/2021
• Supplement Dates FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• 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