MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MIDLINE CATHETERIZATION KIT; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN036127

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Additional customer information: the needle and guide were removed together.The whole system was blocked.It was impossible to insert a new needle.Bleeding.No medical intervention was required.

Event Description

It was reported that the swg (spring wire guide) was stuck in the patient so the needle had to be entirely removed.Three different staff members tried to remove the guide, but they all found it impossible to remove.

Manufacturer Narrative

Qn#(b)(4).The customer returned one arrow midline kit with lidstock containing a spring wire guide (swg) and other components for evaluation.Visual inspection of the swg revealed one bend and many offset coils at the distal end of the swg body.Microscopic examination confirmed the distal weld was fully attached and spherical, this was a nitinol wire so the proximal end is not welded.The guide wire body had a bend at 390mm from the proximal end.There were numerous offset coils from 409-433mm from the proximal end.The length of the swg measured 451mm which is within specifications of 437.5-462.5mm per swg product drawing.The outer diameter of the proximal end of the swg measured 0.453mm which is within specifications of 0.41-0.47mm per swg product drawing.The outer diameter of the returned needle measured 0.03205" which is within specifications of 0.0320-0.0325" per introducer needle cannula graphic.The inner diameter of the needle measured 0.023" which is within specifications of 0.0226-0.0240" per introducer needle cannula graphic.The guide wire was advanced through the returned 21ga introducer needle to functionally test the guide wire.The guide wire passed through with minimal resistance.A manual tug test confirmed that the distal weld was intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with the kit warns the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.Do not apply undue force on guidewire to reduce risk of possible breakage.Do not apply excessive force in removing guidewire or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained and further consultation requested." the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had one bend and multiple offset coils at the distal end of its body.The returned guide wire and introducer needle 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

It was reported that the swg (spring wire guide) was stuck in the patient so the needle had to be entirely removed.Three different staff members tried to remove the guide , but they all found it impossible to remove.

• Brand Name: ARROW MIDLINE CATHETERIZATION KIT
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9693551
• MDR Text Key: 180325666
• Report Number: 3006425876-2020-00135
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: IPN036127
• Device Catalogue Number: EU-02041-ML
• Device Lot Number: 71F19L2322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1