MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Material Deformation (2976)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The spring wire guide was kinked prior to patient use.No patient involvement reported.

Manufacturer Narrative

(b)(4) the customer returned one, opened cvc kit containing multiple components for analysis.The guide wire assembly will be analyzed as part of this complaint investigation.Signs-of-use in the form of biological was observed on the guide wire, which contradicts the customer report that the event was observed before use.Additionally, the guide wire was returned with the distal j-bend partially retracted within the blue advancer tubing.This is not the intended assembly for this device; however, it cannot be determined if the customer retracted during interaction with the device.Visual analysis revealed that the guide wire was severely bent/kinked in several locations across the body.The appearance of the kinking/bending seems consistent with damage due to unintentional user error; however , this cannot be confirmed based on the customer description.The major kinks in the guide wire measured 65mm, 210mm, 220mm, 450mm, and 468mm from the distal tip.The guide wire total length measured 601mm from the distal tip, which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.79mm, which is within the specification limits of.788mm-.826mm per the guide wire graphic.The ifu provided with the kit informs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was inserted through the returned ars/introducer needle subassembly.Minor resistance was observed due to the kinking; however, the guide was able to pass completely through the subassembly.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed several kinks/bends across the guide wire body.The majority of these kinks would have been located within the guide wire tubing.Additionally, the kinks/bends appear consistent with damage due to unintentional user error.Signs-of-use in the form of biological material was also observed, which further contradicts the customer report.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, the root cause cannot be determined as based on the observed signs-of-use and the appearance of the damage.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The spring wire guide was kinked prior to patient use.No patient involvement reported.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11616306
• MDR Text Key: 243907959
• Report Number: 3006425876-2021-00268
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/27/2022
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F20B0330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1