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 Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that during insertion the guide wire kinked and would not pass.The doctor could not proceed with the procedure and finished using a new product.

Manufacturer Narrative

(b)(4).The customer returned multiple components from a cvc kit.The guide wire will be analyzed as part of this complaint investigation.Signs-of-use in the form of biological material was observed on the guide wire tubing.Visual analysis revealed that the guide wire contained one slight kink/bend near the distal end.This resulted in the distal j-bend to be slightly misshapen.Microscopic examination confirmed the kink and revealed that the distal and proximal welds were secure and intact.The kink in the guide wire measured 55mm from the distal weld.The guide wire total length measured 603mm , which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.794mm, which is within the specification limits of.788mm-.826mm per the guide wire graphic.The guide wire was passed through the returned catheter.Little to no resistance was observed.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 the kit informs the user, "although the incidence of spring-wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the wire".The ifu also states, "although the incidence of spring-wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the wire guide".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked near the distal end.Despite this, 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, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that during insertion the guide wire kinked and would not pass.The doctor could not proceed with the procedure and finished using a new product.

• 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: 10032612
• MDR Text Key: 190151685
• Report Number: 3006425876-2020-00380
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

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: 09/25/2020
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F18K1435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1