MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO RX/5MM BASKET DIAMETER/180CM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number 501814RE

Device Problems Stretched (1601); Unraveled Material (1664)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation, but the manufacture report is not yet available.A review of the device history record (dhr) associated with lot 35261340 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.

Event Description

As reported, a 5mm x 180cm angioguard rapid exchange (rx) guidewire system was used; however, during the process of inserting the device, it could not be released when it reached the lesion.Therefore, the device was withdrawn.The product analysis shows a 18cm of length unzipped condition was observed on the delivery sheath located at 31 cm from the distal end, and a 40cm of length unzipped condition was observed on the delivery sheath located at 140 cm from the distal end.There was no reported patient injury.Angiography found a chronic occlusion of the carotid artery followed by carotid artery stent implantation.The device was stored for two weeks.The device was stored, handled and prepped per the instructions per use (ifu).The angioguard was sized larger than the vessel as instructed in the ifu.There was no difficulty experienced when removing the catheter from its packaging.There was no unusual force used at anytime during the procedure.The device did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the device towards the lesion.Sufficient space was allowed between the lesion and the filter basket to prevent interaction between devices.There was no difficulty or resistance noted while crossing the lesion with the device.The target lesion was the proximal tip of the internal carotid artery.The lesion was not calcified.There was no vessel tortuosity.There was seventy percent stenosis.The device was not used for a chronic total occlusion.The procedure was completed using another angioguard.The device will be returned for evaluation.

Manufacturer Narrative

The device has been returned for evaluation, but the manufacture report is not yet available.Due to systems limitation the report was created in error.Additional information is pending and will be sent in upon 30 days after receipt.

Manufacturer Narrative

A angioguard 5mm x 180cm rapid exchange (rx) guidewire system was used; however, during the process of inserting the device, it could not be released when it reached the lesion.Therefore, the device was withdrawn.The product analysis shows a 18cm of length unzipped condition was observed on the delivery sheath located at 31 cm from the distal end, and a 40cm of length unzipped condition was observed on the delivery sheath located at 140 cm from the distal end.Angiography found a chronic occlusion of the carotid artery followed by carotid artery stent implantation.The device was stored for two weeks.The device was stored, handled and prepped per the instructions per use (ifu).The angioguard was sized larger than the vessel as instructed in the ifu.There was no difficulty experienced when removing the catheter from its packaging.There was no unusual force used at any time during the procedure.The device did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the device towards the lesion.Sufficient space was allowed between the lesion and the filter basket to prevent interaction between devices.There was no difficulty or resistance noted while crossing the lesion with the device.The target lesion was the proximal tip of the internal carotid artery.The lesion was not calcified.There was no vessel tortuosity.There was seventy percent stenosis.The device was not used for a chronic total occlusion.The procedure was completed using another angioguard.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of a product ¿rx/5mm basket diameter/180cm¿ was received inside of a clear plastic bag.Device was unpacked in order to perform the visual evaluation.The returned component was the ecgw system.The rest of the components were not returned.The filter basket was found over captured in the delivery sheath.In addition, two unzipped areas were observed at the delivery sheath: a 18 cm of length unzipped condition was observed on the delivery sheath located at 31 cm from the distal end, and a 40 cm of length unzipped condition was observed on the delivery sheath located at 140 cm from the distal end.No damages or anomalies were observed on the returned product.Functional analysis could not be properly performed due to the filter basket is over captured in the delivery sheath.A product history record (phr) review of lot 35261340 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿delivery system- deployment difficulty ¿ unable was confirmed since the device was received over captured.The reported ¿distal tip- unraveled/stretched was confirmed since the tip was found unraveled.However, two unzipped areas were noted at the delivery sheath: a 18 cm of length unzipped condition was observed on the delivery sheath located at 31 cm from the distal end, and a 40 cm of length unzipped condition was observed on the delivery sheath located at 140 cm from the distal end.The exact cause of the observed condition could not be conclusive determined during the analysis.It is difficult to draw a clinical conclusion between the device and the events based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device and vessel characteristics (seventy percent stenosis) may have led to the reported events.According to the instructions for use (ifu) ¿gripping the torque device in one hand and the coil dispenser in the other, pull on the wire until the basket is completely docked into the tip of the deployment sheath.When completely docked, approximately half the filter basket will still be visible out the end of the deployment sheath.¿ additionally, ¿separate the deployment sheath hub from the guidewire by grasping the guidewire proximally in one hand and pulling the hub away from the wire with the thumb and index finger of the other hand.While maintaining the guidewire position, use the hub to peel the deployment sheath up to the hemovalve.Place one hand over the hemovalve and grasp it with the ring and little fingers.Open the hemovalve.Maintain guidewire position by holding the guidewire between the thumb and index finger of the same hand.With the other hand, peel the deployment sheath from the guidewire by pulling on the hub parallel to the axis of the guidewire.Complete the peeling step by pulling on the black deployment sheath.Peeling is complete within a few centimeters of the black to yellow sheath color change.Remove the remaining un-slit sheath using a standard over-the-wire technique.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: RX/5MM BASKET DIAMETER/180CM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11307096
• MDR Text Key: 233591187
• Report Number: 9616099-2021-04254
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 501814RE
• Device Lot Number: 35261340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK STENT
• Patient Age: 69 YR
• Patient Weight: 83