MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 12 FR X 20 CM; CATHETER, HEMODIALYSIS, NON-I

Catalog Number CDC-25122-X1A

Device Problems Break (1069); Material Deformation (2976); Migration (4003)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).User facility contacted to obtain additional information regarding this event.No response received at the time of this report.

Event Description

According to the medwatch ((b)(4)) "upon withdrawing the guidewire from the quinton catheter, post insertion, the physician noted the tip was not "curved" as it normally is but was "straight".The catheter was replaced the next day and dialysis was performed via the catheter.3 days later, a metallic object was observed on the chest x-ray, located in the pulmonary artery.The patient was taken to interventional radiology and the metallic object was successfully removed.The metallic object was found to be the tip of the guidewire which had migrated from the groin insertion site to the pulmonary artery".The original intended procedure: cannulization of the femoral vein for dialysis.

Event Description

According to the medwatch (b)(4) "upon withdrawing the guidewire from the quinton catheter, post insertion, the physician noted the tip was not "curved" as it normally is but was "straight".The catheter was replaced the next day and dialysis was performed via the catheter.3 days later, a metallic object was observed on the chest x-ray, located in the pulmonary artery.The patient was taken to interventional radiology and the metallic object was successfully removed.The metallic object was found to be the tip of the guidewire which had migrated from the groin insertion site to the pulmonary artery".The original intended procedure: cannulization of the femoral vein for dialysis.

Manufacturer Narrative

(b)(4).User facility contacted to obtain additional information regarding this event.No response received at the time of this report.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 complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 12 FR X 20 CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8859551
• MDR Text Key: 153400046
• Report Number: 1036844-2019-00869
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CDC-25122-X1A
• Device Lot Number: 23F18H0452
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/23/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUINTON CATHETER.; QUINTON CATHETER.
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 41 YR