MAUDE Adverse Event Report: CORDIS CORPORATION 5F TEMPO .038 80CM HEPATIC; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SRD5601

Device Problem Difficult to Remove (1528)

Patient Problem Thrombosis (2100)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown hemostatic forceps used for thrombolysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there was difficulty withdrawing the 5f tempo.038 80cm hepatic angiographic catheter and the catheter was kinked during removal.The femoral artery was cut in order to remove the tempo catheter and as a result the foot pulse was week and thrombus was formed which had to be removed.Several attempts were made to remove the tempo catheter and it still could not be removed.It was advised to cut right femoral artery to remove the catheter maintaining inside the iliac artery.The catheter inside the iliac artery was removed successfully by cutting the femoral artery.It was noticed that the foot pulses were week after removal of catheter.Considering that the arterial sheath being placed for a long time will form the thrombus, the angiographic catheter was inserted into right iliac artery from left femoral artery.The angiographic examination showed that the inflation of the suture segment of the right femoral was defected, and the blood flow of the distal segment of the right lower limb artery was slow.The thrombus was removed by hemostatic forceps after removing the original gap seam of the right femoral artery, but ejecting blood, so suturing the gap of the right femoral artery again.The inspection showed the proximal tip and the distal tip of the right femoral artery was pulsing well, the angiographic examination showed the blood flow¿s speed of the lower limb artery was recovered.Two hundred thousand ((b)(4)) units of the urease was injected through the angiographic catheter placing to the middle tip of the right femoral artery.The thrombolysis was performed after the patient went back to the ward.The pulse flow of the right lower limb artery was acceptable and the skin was warm.The hospital has reported this case as an adverse event, so please upgrade this case to an adverse event accordingly.

Manufacturer Narrative

As reported, there was difficulty withdrawing the 5f tempo.038 80cm hepatic angiographic catheter and the catheter was kinked during removal.The femoral artery was cut in order to remove the tempo catheter and as a result the foot pulse was weak and thrombus was formed which had to be removed.Several attempts were made to remove the tempo catheter and it still could not be removed.It was advised to cut right femoral artery to remove the catheter maintaining inside the iliac artery.The catheter inside the iliac artery was removed successfully by cutting the femoral artery.It was noticed that the foot pulses were week after removal of catheter.Considering that the arterial sheath being placed for a long time will form the thrombus, the angiographic catheter was inserted into right iliac artery from left femoral artery.The angiographic examination showed that the inflation of the suture segment of the right femoral was defected, and the blood flow of the distal segment of the right lower limb artery was slow.The thrombus was removed by hemostatic forceps after removing the original gap seam of the right femoral artery, but ejecting blood, so suturing the gap of the right femoral artery again.The inspection showed the proximal tip and the distal tip of the right femoral artery was pulsing well, the angiographic examination showed the blood flow¿s speed of the lower limb artery was recovered.Two hundred thousand (200,000) units of the urease was injected through the angiographic catheter placing to the middle tip of the right femoral artery.The thrombolysis was performed after the patient went back to the ward.The pulse flow of the right lower limb artery was acceptable and the skin was warm.The device was not returned for evaluation.A product history record (phr) review of lot 17832963 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, the reported ¿catheter (body/shaft) - withdrawal difficulty - from vessel, catheter (body/shaft) - kinked/bent - in-patient, and thrombus¿ could not be confirmed and no determination of a conclusive root cause could be made.Vessel characteristics and/or procedural/handling factors may have contributed to the reported events.A thrombus can be caused by anything that prevents your blood from circulating or clotting normally, such as injury to a vein, surgery, certain medications and limited movement.Procedural factors, such as the arterial sheath being in place for a long period of time, may have contributed to the thrombus formation.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters; straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.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.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include, but are not limited to the following: air embolism, hematoma at the puncture site, infection, perforation of the vessel wall.¿ neither the phr review nor the information available suggest that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 5F TEMPO .038 80CM HEPATIC
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9176933
• MDR Text Key: 167131267
• Report Number: 9616099-2019-03264
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032063095
• UDI-Public: 20705032063095
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SRD5601
• Device Catalogue Number: SRD5601
• Device Lot Number: 17832963
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening