MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW 3-L CVC KIT: 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CDC-45703-1A

Device Problem Unraveled Material (1664)

Patient Problems Cardiac Arrest (1762); Death (1802); Hematoma (1884)

Event Date 07/29/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).It is reported that the doctor believes the issue with the device did not contribute to the death of the patient.The cause of death is not determined at the time of this report.It is noted that may factors may have contributed (pe, dissection).

Event Description

It is reported: the patient arrived in the er complaining of sever cheat pain, severe back pain and was in distress.Upon moving the patient to stretcher, the patient immediately became unresponsive and code initiated.At this time the patient had a peripheral iv and meds were administered.The patient required a central line.The doctor placed a central line.This was the first central line by this doctor that he had an issue.The guide wire unraveled during extraction.X-ray of groin was taken to verify no retained fragments in the patient.The patient remained very unstable with several more codes during approx.5 hours in the er.The central line placed by the doctor left a large hematoma close to the insertion site.Another insertion was initiated but not completed because the patient coded and then was pronounced dead.

Event Description

It is reported: the patient arrived in the er complaining of sever cheat pain, severe back pain and was in distress.Upon moving the patient to stretcher, the patient immediately became unresponsive and code initiated.At this time the patient had a peripheral iv and meds were administered.The patient required a central line.The doctor placed a central line.This was the first central line by this doctor that he had an issue.The guide wire unraveled during extraction.X-ray of groin was taken to verify no retained fragments in the patient.The patient remained very unstable with several more codes during approx.5 hours in the er.The central line placed by the doctor left a large hematoma close to the insertion site.Another insertion was initiated but not completed because the patient coded and then was pronounced dead.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the catheter and guide wire and no relevant findings were identified.The ifu provided with the kit cautions the user, "read all package insert warnings, precautions and instructions prior to use.Failure to do so may result in severe patient injury or death." the ifu also warns, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".Additionally, the ifu cautions, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested".The ifu states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.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 3-L CVC KIT: 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8883653
• MDR Text Key: 153976425
• Report Number: 9680794-2019-00312
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• 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: 08/01/2019

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CDC-45703-1A
• Device Lot Number: 13F18L0637
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 09/12/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention