MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 5 FR X 8 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25502

Device Problem Material Deformation (2976)

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

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that prior to patient use during visual inspection, the physician noticed the j tip of the guidewire was slightly bent and "about to break".Another device was obtained for patient use.

Event Description

It was reported that prior to patient use during visual inspection, the physician noticed the j tip of the guidewire was slightly bent and "about to break".Another device was obtained for patient use.

Manufacturer Narrative

(b)(4).The customer returned one guidewire for analysis.Signs-of-use in the form of biological material was observed on the guidewire, which contradicts the customer report that the defect was observed before use.Visual analysis revealed that the guide wire was kinked towards the distal end, as reported by the customer.The customer also provided a photo showing the reported defect.Microscopic examination confirmed the kinking and revealed that the distal and proximal welds were secure and intact.The kink measured 5mm from the distal weld.The guide wire total length measured 451mm, which is within the specification limits of 437.5mm - 462.5mm per the guide wire graphic.The guide wire outer diameter measured.526mm, which is within the specification limits of.51mm-.55mm per the guide wire graphic.Functional inspection was performed per s-15703-112a rev.01 which states "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was passed through a lab inventory introducer needle.The guide wire was able to pass with little to no difficulty.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit 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 kinked guide wire was confirmed through complaint investigation.Signs-of-use were observed which 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 at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 5 FR X 8 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11683328
• MDR Text Key: 246312144
• Report Number: 9680794-2021-00154
• 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: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CS-25502
• Device Lot Number: 14F19M0077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1