MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number CDC-41541-MPK1A

Device Problem Material Deformation (2976)

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

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: the clinician placed the introducer needle in the patient's vessel and had difficulty advancing the wire through the needle.It was reported there was "a lot of drag" and the wire would not move freely inside the needle.The needle and wire were removed from patient and the wire had a "burr" on the distal portion.A new wire was obtained and the procedure completed without incident.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer returned a spring wire guide as part of this complaint investigation.Visual examination revealed that the guide wire was kinked severely at two locations near the distal end.Microscopic examination confirmed the kinks.The distal weld appeared spherical and intact.No other defects or anomalies were observed.Visual inspection of the introducer needle could not occur since the needle was not returned.The kinks were located at 9mm and 30mm from the distal tip.The guide wire measured 45.0 cm, which is within the specification limits of 43.75cm-46.25cm per guide wire product drawing.The outer diameter measured.456mm , which is within the specification limits of.41mm-.47mm per guide wire product drawing.Functional inspection was performed to recreate the product's intended use.The ifu provided with this kit states "advance guidewire into introducer needle." the distal end of the guide wire was passed through a lab inventory 21 ga introducer needle.The guide wire was able to pass through each with little to no resistance.A manual tug test confirmed the distal weld was intact, full and spherical.A device history record review did not reveal any manufacturing related issues.The ifu provided with this kit includes the following warnings, cautions and instructions for the user: "do not cut guidewire to alter length." "do not apply undue force on guidewire to reduce risk of possible breakage." "clinicians must be aware of the potential for entrapment of guidewire by any implanted device in circulatory system.It is recommended that if patient has a circulatory system implant, catheter procedure be done under direct visualization to reduce risk of guidewire entrapment." "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause catheter component damage or breakage.If placement damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." "do not alter the guidewire or any other kit/set component during insertion, use or removal." the report of a kinked guide wire was confirmed through examination of the returned sample.The guide wire contained two kinks near the distal end.The guide wire met all functional and dimensional requirements during investigation testing.A device history record review was performed and no relevant findings were found.However, the introducer needle was not returned by the customer, therefore, the probable root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: the clinician placed the introducer needle in the patient's vessel and had difficulty advancing the wire through the needle.It was reported there was "a lot of drag" and the wire would not move freely inside the needle.The needle and wire were removed from patient and the wire had a "burr" on the distal portion.A new wire was obtained and the procedure completed without incident.The patient's condition is reported as fine.

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11348014
• MDR Text Key: 232553906
• Report Number: 1036844-2021-00026
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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 Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1