MAUDE Adverse Event Report: CORDIS CORPORATION 5MM BASKET, MEDIUM SUPPORT,; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Catalog Number 501814RMC

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 35261803 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.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 part of 5mm angioguard rapid exchange (rx) medium support emboli capture guidewire system became jailed.They were unable to remove the wire.After many attempts, wire broke.Back of wire came out of body as one piece.They retrieved angioguard basket and proximal end of wire with a lasso snare successfully.The angioguard was in left internal carotid.Express unknown stent was placed in brachiocephalic artery.The device was stored as per labeling and opened in sterile filed.The device will be returned for evaluation.

Manufacturer Narrative

The part of an angioguard rapid exchange (rx) medium support 5mm emboli capture guidewire system became jailed.They were unable to remove the wire.After many attempts, wire broke.Back of wire came out of body as one piece.They retrieved angioguard basket and proximal end of wire with a lasso snare successfully.The angioguard was in left internal carotid.Express unknown stent was placed in brachiocephalic artery.The device was stored as per labeling and opened in sterile filed.The device was returned for analysis.A non-sterile fracture- separated distal section of a 5mm basket, medium support, embolic protection device along with an unknown lasso snare device was received for analysis inside a plastic bag.Neither the associated fracture- separated proximal section of the unit nor any other embolic protection device component was returned for evaluation.Per visual analysis, the mentioned separated section was received captured by the unknown lasso snare.Also, unraveled/ stretched condition could be observed in the floppy distal tip of the angioguard.The area of the angioguard separation seemed twisted damaged and elongated.No other anomalies observed.Per microscopic analysis, the fractured/ separated section of the angioguard was sent to sem analysis (scanning electron microscope) to determine the root cause of the fractured/ separated condition.Results showed that the separated area of the 5 mm basket, medium support wire unit presented evidence of plastic deformation and ductile dimples on the wire of the unit.The plastic deformations and the ductile dimples are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the material of the wire was induced to a tensile force that exceeded the wire material yield strength prior to the separation.No other anomalies were observed during scanning electron microscope analysis.A product history record (phr) review of lot 35261803 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter basket-withdrawal difficulty - snagged/caught¿ as well as the ¿ecgw (embolic capture guidewire)- fractured-separated - in-patient¿ were both confirmed.Due to the fracture- separated condition of the unit and the way the separated distal section of the angioguard (returned with lasso snared) was received.However, per scanning electron microscope analysis, the unit presented evidence of plastic deformation and ductile dimples on the wire of the unit.Due to the plastic deformations and the ductile dimples observed in the unit, it is assumed that the material of the wire was induced to a tensile force that exceeded the wire material yield strength prior to the separation.Nonetheless, the actual cause of the fractured-separated damage condition of the device could not be conclusively determined during the analysis.Based on the investigation conducted, it reasonable to consider that procedural and or handling factors such as the user¿s interaction with the device led to the reported events.Product analysis revealed tensile forces which occur when the user applies an excessive amount of force in which exceeds the wire material yield strength of the device, causing the reported separation.Moreover, vessel characteristics although unknown, may have contributed to the reported events.According to the instructions for use (ifu), ¿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, which meets resistance.Resistance may be felt and/or observed using fluoroscopy by noting any buckling of the guidewire tip.Determine the cause of resistance using fluoroscopy and take the necessary remedial action.¿ neither the phr review nor the scanning electron microscope analysis nor the product evaluation suggests that the reported events could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken.

• Brand Name: 5MM BASKET, MEDIUM SUPPORT,
• 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: 12205969
• MDR Text Key: 263588264
• Report Number: 9616099-2021-04720
• 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
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 501814RMC
• Device Lot Number: 35261803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN STENT
• Patient Outcome(s): Required Intervention