MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO ANGIOGUARD RX 6.00MM 180; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 601814RE

Device Problem Fracture (1260)

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

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

When preparing to use 6mm x 180cm extra support basket angioguard rapid exchange (rx) emboli capture guidewire system, according to the standard operation, when shaping the head, it was found that the protective angioguard filter was partially separated from the angioguard.There was difficulty removing the device from the packaging as the filter screen could not be fully contained within the deployment sheath.There was no reported patient injury.Another angioguard was used to complete the procedure.The device prepped according to the instruction for use (ifu).There were no excess force used during prep.There were no damages noted to the device packaging.The device was stored in accordance to the ifu in the cath lab for one week.The device will be returned for analysis.

Manufacturer Narrative

When preparing to use 6mm x 180cm extra support basket angioguard rapid exchange (rx) emboli capture guidewire system, according to the standard operation, when shaping the head, it was found that the protective angioguard filter was partially separated from the angioguard.There was difficulty removing the device from the packaging as the filter screen could not be fully contained within the deployment sheath.There was no reported patient injury.Another angioguard was used to complete the procedure.The device prepped according to the instruction for use (ifu).There was no excess force used during prep.There were no damages noted to the device packaging.The device was stored in accordance to the ifu in the cath lab for one week.The product was returned for analysis.A non-sterile unit of a product angioguard rx ¿angioguard rx 6.00mm 180¿ was received inside of a clear plastic bag.The device was unpacked to perform the visual evaluation.Per visual analysis, the device filter basket stent was observed in good conditions, the delivery sheath and the capture sheath returned was also in good conditions.The torque device was affixed to the distal end of the unit.No anomalies were observed at naked eye.Functional analysis was not performed according to procedure since no deployment could be performed due the condition of the polyurethane membrane.Microscopical analysis was performed to review this condition.Per microscopic analysis, the unit was observed under the vision system and the polyurethane membrane could not be re-enter on the sheath due to the form of the membrane that impede the entry on the sheath.The nitinol struts of the basket were found with no damages.Neither compressions nor distortions were observed on the unit.A product history record (phr) review of lot 35261727 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿ecgw (embolic capture guidewire) fractured-separated - during prep¿ could not be confirmed as the guidewire was not returned with the device.The reported ¿delivery system - premature deployment¿ was not confirmed as functional analysis was not performed according to procedure, no deployment could be performed due the condition of the polyurethane membrane.The exact cause of reported events could not be conclusively determined during analysis.It is likely that procedural factors and handling of the device may have contributed to the events reported.According to the instructions for use, ¿while 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.Remove the last anti-migration clip.Open the torque device.While gripping the torque device in one hand and the proximal end of the guidewire in the other, pull the wire through the torque device until the proximal end of the deployment sheath hub engages the torque nut.Lock the torque device onto the guidewire; ensure the deployment sheath hub remains engaged with the torque nut.Pull the wire and deployment sheath out of the dispenser coil.The deployment sheath is now prepped and ready for use.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: ANGIOGUARD RX 6.00MM 180
• 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: 10979273
• MDR Text Key: 220705655
• Report Number: 9616099-2020-04114
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 601814RE
• Device Catalogue Number: 601814RE
• Device Lot Number: 35261727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1