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

Model Number 501814RE

Device Problem Fracture (1260)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 35265330 presented no issues during the manufacturing process that can be related to the reported event.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 5mm basket diameter/180cm angioguard rx emboli capture guidewire was unable to be inserted into the sheath due to the the angioguard filter, which was detached from the wire.Upon opening the package, it was noted that the deployment sheath tip was not fully seated in the filter basket introducer.It was already broken upon opening package.A 6.0mm angioguard was then used and the procedure was completed successfully.There were no reports of patient injury.The product was stored, handled, inspected and prepped according to the instructions for use (ifu) and was already broken prior to use.The device was intended for use in a carotid stenting procedure.The torque device locked onto the guidewire.The anti-migration clip located closest to the filter introducer was left in place until after the filter basket was docked into the deployment sheath.The proximal end of the deployment sheath was in contact with the torque nut prior to removing the device from the coil dispenser.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: the 5mm basket diameter/180cm angioguard rx emboli capture guidewire was unable to be inserted into the sheath due to the angioguard filter which was detached from the wire.Upon opening the package, it was noted that the deployment sheath tip was not fully seated in the filter basket introducer.It was already broken upon opening package.A 6.0mm angioguard was then used and the procedure was completed successfully.There were no reports of patient injury.The product was stored, handled, inspected and prepped according to the instructions for use (ifu) and was already broken prior to use.The device was intended for use in a carotid stenting procedure.The torque device locked onto the guidewire.The anti-migration clip located closest to the filter introducer was left in place until after the filter basket was docked into the deployment sheath.The proximal end of the deployment sheath was in contact with the torque nut prior to removing the device from the coil dispenser.The product was returned for analysis.One non-sterile angioguard rx/5mm 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 embolic capture guide wire with the torque device not affixed and the capture sheath were returned for evaluation.The filter basket was noted deployed.No other anomalies were observed on the components during the analysis.Functional analysis could not be performed, due to the condition of the unit as received, and since the deployment sheath was not returned for evaluation, only the ecgw which was already peeled off.A product history record (phr) review of lot 35265330 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿delivery system- loading (docking) difficulty - through introducer¿ was not confirmed through analysis of the returned device as the concomitant sheath was not returned and the condition of the returned device was not conducive for functional testing.The reported ¿ecgw (embolic capture guidewire) - fractured/separated - during prep¿ was not confirmed through analysis of the returned device as no fractures or separations were noted.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the 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.Do not use defective equipment.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: RX/5MM 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
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 03246
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15369385
• MDR Text Key: 302938850
• Report Number: 1016427-2022-05419
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 10705032054775
• UDI-Public: (01)10705032054775(17)240331(10)35265330
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 501814RE
• Device Catalogue Number: 501814RE
• Device Lot Number: 35265330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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
• Treatment: 6.0MM ANGIOGUARD, UNKNOWN SHEATH