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

Model Number 601814RMC

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 0.014 inches x 180 cm x 6mm filter basket, medium support angioguard rx emboli capture guidewire (gc) system would not pull out of hoop, therefore, it was released unsheathed/unraveled.There was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

An angiogurard rx 6mm x 180 cm filter basket, medium support emboli capture guidewire (gc) system would not pull out of the hoop.Therefore, it was released unsheathed/unraveled.There was no reported patient injury.Multiple attempts to obtain additional information were made without success.The device was 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.Without the return of the device for analysis and based on the limited information provided, the reported ¿distal tip- unraveled/stretched - during prep¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors may have contributed to the reported event.According to the instructions for use, which are not intended as a mitigation of risk, ¿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¿.Neither the phr review 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.

• 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
• MDR Report Key: 9262857
• MDR Text Key: 202936117
• Report Number: 1016427-2019-03474
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 601814RMC
• Device Catalogue Number: 601814RMC
• Device Lot Number: 35238004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 114