MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04301

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

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the guide wire bent during the puncture.The guide wire was difficult to advance.This issue brought pain to the patient.The guide wire and needle were immediately pulled, pressure applied to the site and a new device was successfully inserted.

Manufacturer Narrative

Qn#(b)(4).The customer returned one spring wire guide within the advancer tubing with a lidstock.The guide wire showed evidence of use.The guide wire was observed to have two gradual bends along the body.Microscopic examination confirmed both welds were present and were observed to be full and spherical.The bends in wire body were located at 150-180 mm and at 560-570 mm from the proximal tip.The overall length of the guide wire measured 603 mm which is within the specification of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.796 mm which is within the specification of 0.788-0.826 mm per guide wire product drawing.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not cut spring-wire guide to alter length.Do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the report that the guide wire kinked during use was confirmed through examination of the returned sample.The bends in the wire body were located at 150-180 mm and at 560-570 mm from the proximal tip.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the guide wire bent during the puncture.The guide wire was difficult to advance.This issue brought pain to the patient.The guide wire and needle were immediately pulled, pressure applied to the site and a new device was successfully inserted.

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9376242
• MDR Text Key: 179122908
• Report Number: 3006425876-2019-00938
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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: 03/31/2021
• Device Catalogue Number: ES-04301
• Device Lot Number: 71F16D1607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1