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

Catalog Number 501814RE

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 35235479 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, after opening the packaging for an angioguard (rx/5mm basket diameter/180cm), the guidewire was found to be separated from the sheath and could not be used normally.There was no patient injury reported.The target lesion was the right common carotid artery.The intended location was not located at the carotid bifurcation.The angioguard was sized larger than the vessel as instructed in the ifu.There was no thrombus present prior to, at, or after the lesion site.The product was stored and handled as per the instructions for use (ifu).When opening the package, the deployment sheath tip still was not fully seated in the filter basket introducer.There was no difficulty docking the filter basket into the deployment sheath.The product was inspected and prepped according to the ifu.The capture sheath coil dispenser was flushed according to the ifu.There was no difficulty encountered while flushing the filter introducer and deployment sheath.There was no saline noted within the coil dispenser at the green deployment sheath hub.The device did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the device towards the lesion.There was no unusual force used at any time during the procedure.There was no difficulty or resistance noted while crossing the lesion with the device.The device did not have to pass through a previously placed stent.The lesion was not post-dilated after stent implantation.The proximal end of the deployment sheath was in contact with the torque nut prior to removing the device from the coil dispenser.The procedure was completed with another product and the treatment was successful.Additional procedural details were requested but are unknown.

Manufacturer Narrative

After further review of additional information received the following sections event, pma/510k, if follow-up, what type, and adverse event problem have been updated accordingly.Additional information was received indicating that the device was not used in the patient after the malfunction was noted.After opening the packaging for an angioguard (rx/5mm basket diameter/180cm), the guidewire was found to be separated from the sheath and could not be used normally.There was no patient injury reported.The target lesion was the right common carotid artery.The intended location was not located at the carotid bifurcation.The angioguard was sized larger than the vessel as instructed in the ifu (instructions for use).There was no thrombus present prior to, at, or after the lesion site.The product was stored and handled as per the ifu.When opening the package, the deployment sheath tip still was not fully seated in the filter basket introducer.There was no difficulty docking the filter basket into the deployment sheath.The product was inspected and prepped according to the ifu.The capture sheath coil dispenser was flushed according to the ifu.There was no difficulty encountered while flushing the filter introducer and deployment sheath.There was no saline noted within the coil dispenser at the green deployment sheath hub.There was no unusual force used at any time during the procedure.The lesion was not post-dilated after stent implantation.The proximal end of the deployment sheath was in contact with the torque nut prior to removing the device from the coil dispenser.The procedure was completed with another product and the treatment was successful.Additional procedural details were requested but are unknown.The product was returned for analysis.One non-sterile rx/5mm basket diameter/180cm embolic protection device, along with a deployment sheath and a capture sheath, was received for analysis inside a plastic bag.Neither original packaging nor coil dispenser was returned for analysis.Per visual analysis the basket filter was observed deployed.Also, an unzipped condition of the deployment sheath was observed on the delivery sheath from 26.0 cm to 34.0 cm from the delivery sheath distal end.Per microscopic analysis, no anomalies were noted either on the basket filter membrane or on the struts of the basket.Functional analysis was not performed due to the unzipped damaged condition of the delivery sheath.A product history record (phr) review of lot 35235479 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¿ was not confirmed through analysis of the returned device.However, an unzipped damaged condition was observed on the delivery sheath.The exact cause of the reported event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event when attempting to constrain the basket in the delivery sheath.According to the instructions for use, which is not intended as a mitigation of risk ¿prior to the interventional procedure, all equipment and packaging, including the angioguard rx emboli capture guidewire system, should be inspected and examined carefully for defects.Check guidewire, filter basket, deployment sheath, capture sheath, and capture sheath rx port region (approximately 30 cm from the distal tip) for bends, kinks, or other damage.Do not use defective equipment.¿ 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/preventive action will be taken at this time.

• Brand Name: RX/5MM BASKET DIAMETER/180CM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8810045
• MDR Text Key: 151770221
• Report Number: 1016427-2019-03055
• 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: foreign,health professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 501814RE
• Device Lot Number: 35235479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/21/2019
• Supplement Dates Manufacturer Received: 07/19/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1