MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-21242-X1A

Device Problem Material Deformation (2976)

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

Event Date 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The physician felt resistance when trying to advance the wire.She attempted multiple times but felt like she was getting "hung up" on the needle.A new wire was obtained for use and the catheter was placed without any problem.No patient injury or consequence reported.The patient's condition was reported as critical.

Manufacturer Narrative

Qn#(b)(4).The actual device was not returned; however, the customer provided two photos for evaluation.Visual inspection of the photos revealed a distinct kink near the distal j-tip.The guide wire also contained obvious signs of use in the form of biological material.However, a full visual inspection could not be performed as no sample was returned for analysis.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 customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photos.However, complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The physician felt resistance when trying to advance the wire.She attempted multiple times but felt like she was getting "hung up" on the needle.A new wire was obtained for use and the catheter was placed without any problem.No patient injury or consequence reported.The patient's condition was reported as critical.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11658288
• MDR Text Key: 245535671
• Report Number: 1036844-2021-00068
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K011761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CDC-21242-X1A
• Device Lot Number: 23F20D0131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1