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

Catalog Number ASK-21242-DU

Device Problems Labelling, Instructions for Use or Training Problem (1318); Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problems Stroke/CVA (1770); Death (1802); Injury (2348)

Event Date 12/16/2019

Event Type  Death  

Manufacturer Narrative

Qn# (b)(4).Potential lot# - 23f17b0115.All three events captured in the following mdrs: mdr #1036844-2020-00119 (stroke).Mdr #1036844-2020-00120 (limb amputation).(stroke & death).

Event Description

The information is reported by the doctor as: i am writing to share concerns about device safety with the arrowg+ard blue mac catheter.We have observed 3 similar cases in the past year in our institution associated with this device, resulting in 3 arterial injuries, 2 strokes, one limb amputation, and one death.Our subsequent simulation of the device insertion demonstrated that the dilator can puncture the posterior vessel wall, potentially damaging adjacent structures, when the guidewire is not inserted to sufficient depth.Under these conditions, the sharp tip of the dilator is not protected by protruding guidewire and can directly contact and penetrate the posterior vessel wall.Without sufficient wire to guide it, the dilator follows a straight trajectory from the skin surface , increasing the likelihood that it will penetrate the posterior vessel wall, rather than following the vessel lumen.The kit instructions do not provide instructions on appropriate guidewire insertion depth, and the guidewire is not marked to indicate appropriate insertion depth.The 45cm guidewire provided in the kit may contribute to the risk of this complication; a longer (60cm) guidewire is provided in your triple- lumen catheter kit.The 45cm guidewire does not provide sufficient length within the target vessel if the operator allows greater than approximately 10cm of guidewire external to the patient, to prevent the wire from embolizing into the patient.The doctor reports that this patient developed a subclavian artery injury with embolic stroke and death.Medwatch (mw5093647) provides the following information: the mac device was inadvertently placed into the junction of the rt.Carotid artery and subclavian artery during an attempted internal jugular vein cannulation.The resulting arterial injury required a surgical repair and the patient subsequently suffered an embolic stroke followed by death.

Event Description

The information is reported by the doctor as: i am writing to share concerns about device safety with the arrowg+ard blue mac catheter.We have observed 3 similar cases in the past year in our institution associated with this device, resulting in 3 arterial injuries, 2 strokes, one limb amputation, and one death.Our subsequent simulation of the device insertion demonstrated that the dilator can puncture the posterior vessel wall, potentially damaging adjacent structures, when the guidewire is not inserted to sufficient depth.Under these conditions, the sharp tip of the dilator is not protected by protruding guidewire and can directly contact and penetrate the posterior vessel wall.Without sufficient wire to guide it, the dilator follows a straight trajectory from the skin surface , increasing the likelihood that it will penetrate the posterior vessel wall, rather than following the vessel lumen.The kit instructions do not provide instructions on appropriate guidewire insertion depth, and the guidewire is not marked to indicate appropriate insertion depth.The 45cm guidewire provided in the kit may contribute to the risk of this complication; a longer (60cm) guidewire is provided in your triple- lumen catheter kit.The 45cm guidewire does not provide sufficient length within the target vessel if the operator allows greater than approximately 10cm of guidewire external to the patient, to prevent the wire from embolizing into the patient.The doctor reports that this patient developed a subclavian artery injury with embolic stroke and death.Medwatch (mw5093647) provides the following information: the mac device was inadvertently placed into the junction of the rt.Carotid artery and subclavian artery during an attempted internal jugular vein cannulation.The resulting arterial injury required a surgical repair and the patient subsequently suffered an embolic stroke followed by death.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The customer stated that the "guidewire is not marked to indicate appropriate insertion depth"; however, a review of the guide wire product drawing for this kit shows that the guide wire has three markings length on the body at 10cm, 20cm and 30cm.Without the samples returned for evaluation, it cannot be determined if the guide wire in the kit met the specifications defined on the drawing.The customer also stated, "the 45cm guidewire does not provide sufficient length within the target vessel if the operator allows greater than approximately 10cm of guidewire external to the patient." the guide wire included in this kit is 45 cm while the dilator is approximately 22 cm.This indicates that at least 10 cm of guide wire can be external to the patient.However, the actual length of the guide wire and dilator could not be measured as the sample was not provided.The instructions-for-use provided with this kit warns the user, "do not apply excessive force in removing guide wire, dilator or access device.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the ifu also warns the user, "do not leave tissue dilator in place as an indwelling catheter to minimize the risk of possible vessel wall perforation.".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 MAC KIT: 2-L 9 FR DISTAL X 11.5 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9912229
• MDR Text Key: 186008299
• Report Number: 1036844-2020-00118
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-21242-DU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.
• Patient Outcome(s): Death; Life Threatening; Other; Required Intervention