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

Model Number 501814RE

Device Problems Stretched (1601); Unraveled Material (1664); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

As reported, during a carotid artery stenting case, the angioguard did not release in the sheath (the marker bands on the filter struts did not fully opposed to the vessel wall).Additional information was received and unzipped conditions of 13.5 cm and 59 cm were observed at 28 cm and 91 cm from the deployment sheath distal end.There was no patient injury.The target lesion is the carotid artery which was moderately tortuous and seventy percent (70%) stenosis; there was no calcification.The intended lesion was located at the carotid bifurcation.The target lesion vessel diameter is 6mm.The device was 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.There were no issues with the device advancing through the sheath.There was no difficulty tracking towards the lesion.The angioguard was sized larger than the vessel as instructed in the ifu.The device did pass through an acute bend.The lesion was pre-dilated prior to stent implantation using a non cordis (3*20¿4*20) balloon catheter to ten (10) atmosphere (atm).Sufficient space was allowed between the lesion and the filter basket to prevent interaction between devices.Both proximal and distal markers positioned was distal to the lesion being treated.Complete deployment of the filter basket was confirmed under fluoroscopy.The marker bands on the filter struts did not fully opposed to the vessel wall.The hemovalve was closed after filter basket deployment.The device was stored in the lab per ifu for one month.The device will be returned for analysis.One non-sterile rx/5mm basket diameter/180cm angioguard system was received for analysis inside a plastic bag.The angioguard was received inserted in the deployment sheath.The filter basket was received captured in the deployment sheath and the filter caught in the deployment sheath.The distal tip was observed kinked and a section of the coil wire showed an unraveled\stretched condition; also, unzipped conditions of 13.5 cm and 59 cm were observed at 28 cm and 91 cm from the deployment sheath distal end.No other anomalies were observed on the received product.After removing the filter basket from the deployment sheath, the filter basket was reviewed under vision system and it was observed that the filter basket was fully deployed, as expected and no anomalies or damages were observed.A device history record (dhr) review of lot 35232433 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿delivery system- deployment difficulty - partial¿ was not confirmed since once the filter was removed from the deployment sheath, this was fully deployed, as expected.After analysis of the received device, the distal tip was observed with a kink condition, and a section of the coil wire exhibited and unzipped conditions.The exact cause of theses events experienced by the customer could not be conclusively determined.Vessel characteristics of tortuosity, device passing through acute bends and vessel stenosis may have contributed to the reported event.Also, procedural factors may have contributed to those events.The product information for safety warns torquing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation.Always advance or withdraw the guidewire slowly.Never push, auger, withdraw or torque a guidewire that meets resistance.Resistance may be felt and/or observed using fluoroscopy by noting any buckling of the guidewire tip.Determine the cause of resistance under fluoroscopy and take the necessary remedial action.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/ preventive action will be taken at this time.

Event Description

As reported ,the angioguard did not release in the sheath (the marker bands on the filter struts did not fully opposed to the vessel wall).Additional information was received and an unzipped conditions of 13.5 cm and 59 cm were observed at 28 cm and 91 cm from the deployment sheath distal end.There was no patient injury.The target lesion is the carotid artery which was moderately tortuous and seventy percent (70%) stenosis; there was no calcification.The intended lesion was located at the carotid bifurcation.The target lesion vessel diameter is 6mm.The device was prepped according to the instruction for use (ifu).There was no excess force used during prep.There was no damages noted to the device packaging.There were no issues with the device advancing through the sheath.There was no difficulty tracking towards the lesion.The angioguard sized is larger than the vessel as instructed in the ifu.The device did pass through an acute bend.The lesion was pre-dilated prior to stent implantation using a non cordis (3*20¿4*20) balloon catheter to ten (10) atmosphere (atm).Sufficient space was allowed between the lesion and the filter basket to prevent interaction between devices.Both proximal and distal markers positioned was distal to the lesion being treated.Complete deployment of the filter basket was confirmed under flouro.The marker bands on the filter struts did not fully opposed to the vessel wall.The hemovalve closed after filter basket deployment.The device was stored in the cath lab per ifu for one month.The device will be returned for analysis.

• Brand Name: RX/5MM BASKET DIAMETER/180CM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7204276
• MDR Text Key: 98069169
• Report Number: 1016427-2018-00988
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/18/2018

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: 11/30/2018
• Device Model Number: 501814RE
• Device Catalogue Number: 501814RE
• Device Lot Number: 35232433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/20/2017
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1