MAUDE Adverse Event Report: CORDIS CORPORATION CATH ST 5F MP A2 (I) 125CM 2SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 532508

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.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

During use of the angiographic multipurpose super torque catheter for transarterial chemoembolization, the physician reported that the catheter was stuck in the artery and then the hub was broken (cracked) during infusion.Additional information was received and there was resistance with the guidewire.There was no patient injury.The devices were removed successfully but with some difficulty.It happened with two catheters with the same lot numbers.The target was arteria hepatica which was slightly tortuous and the lesion was treated for total chronic occlusion in the past three month.The devices were prepped per the instruction for use (ifu) with no defects noted.A radial approach was used.A contralateral approach wasn't used.There were no difficulty tracking the device towards the lesion or through the vessel.The catheter has never been in an acute bend.The device was stored in the cath lab per the ifu.The product was not returned but is available as the lab has the sample.

Manufacturer Narrative

During use of two angiographic multipurpose super torque catheters for transarterial chemoembolization, the physician reported that the catheters were stuck in the artery and the hubs were broken (cracked) during infusion.Resistance with the guidewire was also encountered.The devices were removed successfully but with some difficulty.There was no patient injury.It happened with two catheters with the same lot numbers.The target was the hepatic artery which was slightly tortuous, and the lesion was treated for a total chronic occlusion in the past three months.The devices were prepped per the instruction for use (ifu) with no defects noted.A radial approach was used.There was no difficulty tracking the devices towards the lesion or through the vessel.The catheters were not in an acute bend.The devices were stored in the cath lab per the ifu.Multiple attempts to obtain additional information were unsuccessful, no other information was reported.The devices were not returned for analysis.A product history record (phr) review of lot 17806388 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿luer hub ¿ catheters cracked - during use¿,¿ catheter (body/shaft) withdrawal difficulty - from vessel¿, and ¿catheter (body/shaft) resistance/friction - in-patient¿ were not confirmed as the devices were not returned for analysis and procedural films were not received.The exact cause of the reported events could not be conclusively determined.Vessel characteristics, such as tortuosity, as well as procedural factors, such as the off-label use of chemoembolization and resistance encountered with the guidewire and when attempting to remove the catheter may have contributed to the events according to the instructions for use (ifu), which is not intended as a mitigation, ¿indications: cordis catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.Warnings: do not expose to organic solvents.Do not use with ethiodol or lipiodol contrast media, or other such contrast media which incorporates the components of these agents.Do not exceed maximum pressure rating printed on product label and hub.Precautions: store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported events; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: CATH ST 5F MP A2 (I) 125CM 2SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8207918
• MDR Text Key: 131773698
• Report Number: 9616099-2019-02607
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032011706
• UDI-Public: 20705032011706
• Combination Product (y/n): N
• PMA/PMN Number: K915836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 02/06/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 532508
• Device Catalogue Number: 532508
• Device Lot Number: 17806388
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1