MAUDE Adverse Event Report: CORDIS CORPORATION 6MM BASKET, MEDIUM SUPPORT,; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Two 6mm medium support angioguard filters baskets were damaged when the edge of the baskets were distorted with a burr on the side as they were pulled from the holder.They were not used in a patient and there was no patient injury.They were stored as per the labeling and opened in a sterile field.The basket caught or snagged on the edge of holder and caused the basket to become distorted.The physician did not feel comfortable using the product.This happened a second time with a different person prepping the filter.The filters were prepped according to ifu (instructions for use).The products were not returned for analysis.A product history record (phr) review of lot 35238004 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter basket damaged - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event.According to the precautions in the safety information of the instructions for use, ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, kinks, or damage of the filter basket assembly.The deployment and capture sheaths are delicate instruments and should be handled carefully.Prior to use, and when possible during the procedure, inspect the deployment sheath, capture sheath, and capture sheath rx port region (approximately 30 cm from the distal tip) for bends, kinks, or other damage.Inject 10 ml of saline to purge all air from the deployment sheath and filter basket (ensure distal tip of the deployment sheath is inside the filter basket introducer tip prior to purging the system).Flushing is complete when saline is seen within the coil dispenser at the green deployment sheath hub.Disconnect syringe.Remove the two proximal (closest to the torque device) anti-migration clips holding the guidewire in the dispenser coil.Ensure the torque device is locked onto the guidewire.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 of the end of the deployment sheath.¿ neither the phr 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.Please note that this is one of two devices associated with the reported event and the related manufacturing report number is 1016427-2019-03320.

Event Description

As reported by the sales rep: two 6mm medium support angioguard filters baskets were damaged.They were not used in a patient and there was no patient injury.They will not be returned for analysis.They were stored as per the labeling and opened in a sterile field.The edge of the baskets were distorted with a burr on the side as they were being pulled from the holder.The basket caught or snagged on the edge of holder and caused the basket to become distorted.The physician did not feel comfortable using the product.This happened a second time with a different person prepping the filter.The filters were prepped according to ifu.

• Brand Name: 6MM BASKET, MEDIUM SUPPORT,
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014
• Manufacturer Contact: karla castro ; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9070219
• MDR Text Key: 195271814
• Report Number: 1016427-2019-03321
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 601814RMC
• Device Lot Number: 35238004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2019
• 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