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)

Patient Problems Stroke/CVA (1770); Embolism (1829)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Potential lot# - 23f17b0115.All three events captured in the following mdrs: mdr #1036844-2020-00120 (limb amputation), mdr #1036844-2020-00118 (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 was discharged to an outpatient subacute rehabilitation facility and neurologic deficits largely resolved.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer report indicated that the guide wire did not have length markings and was not long enough for the dilator; however, the guide wire supplied in this kit has 10cm, 20cm and 30cm marker bands and has sufficient length for use with the dilator provided in the kit.Without a sample returned to evaluate, the customer reported defect could not be confirmed.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.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.

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 was discharged to an outpatient subacute rehabilitation facility and neurologic deficits largely resolved.

• 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: 9865371
• MDR Text Key: 188215214
• Report Number: 1036844-2020-00119
• 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: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASK-21242-DU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention