MAUDE Adverse Event Report: CORDIS CORPORATION RX/4MM BASKET DIAMETER/180CM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 401814RM

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

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, the umbrella of a 4mm x 180cm medium support angioguard rapid exchange (rx) emboli capture guidewire system was broken.The damage noted was umbrella fracture.The act maintained at 300 while the angioguard was deployed.The product was stored and handled according to the ifu.There product was inspected and prepped according to the instructions for use.Umbrella fracture was noted to the device prior to use.There was filter basket deformation.The device will be returned for evaluation.There was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

After further reviewed of additional information received the following sections have been updated accordingly :g3g4,g6,h1,h2,h3 and h6.The umbrella of a 4mm x 180cm medium support angioguard rapid exchange (rx) emboli capture guidewire system was broken.The damage noted was umbrella fracture.The act maintained at 300 while the angioguard was deployed.The product was stored and handled according to the ifu.The product was inspected and prepped according to the instructions for use.Umbrella fracture was noted to the device prior to use.There was filter basket deformation.There was no reported patient injury.The device was returned for analysis.One non-sterile rx/4mm basket diameter/180cm unit was received coiled for analysis inside a plastic bag.The device was unpacked to proceed with the product evaluation.During visual inspection, the delivery sheath with the torque device already affixed, the filter introducer, and the peel away introducer was returned for analysis.The filter basket was observed separated of some portions of the component.No other anomalies were observed during the analysis at naked eye.Per microscopic analysis, results showed that the separated struts located on the basket filter from the angioguard rx/4 mm basket diameter/180 cm unit presented evidence of ductile dimples and plastic deformation.This was found on the separated area for both struts.The ductile dimples and plastic deformation observed on the struts, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the basket filter material was induced to a tensile force that exceeded the strut material yield strength prior to the separation.No other anomalies were observed during microscopic analysis.A product history record (phr) review of lot 35238227 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter basket ¿ fractured¿ was confirmed since a fracture/separated struts were found on the filter basket.The unit presented evidence of ductile dimples and plastic deformation that were found on the separated area for both struts.The ductile dimples and plastic deformation observed on the struts, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the basket filter material was induced to a tensile force that exceeded the strut material yield strength prior to the separation.Handling factors such as the user¿s interaction with the device during device preparation may have led to the reported event.Per the instructions for use (ifu) ¿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.¿ additionally, during device preparation, the ifu states ¿when completely docked, approximately half the filter basket will still be visible out the end of the deployment sheath.¿ if this step is not followed correctly, it is likely that the device will show signs of an applied tensile force.The investigation revealed supporting evidence that the device was submitted to an inappropriate force causing ductile dimples and plastic deformation observed on the struts which are commonly associated with separations caused by material tensile overload.Neither the phr review nor the product analysis suggests that the event reported could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: RX/4MM BASKET DIAMETER/180CM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12437211
• MDR Text Key: 271660473
• Report Number: 1016427-2021-05371
• 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: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 401814RM
• Device Catalogue Number: 401814RM
• Device Lot Number: 35238227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1