MAUDE Adverse Event Report: ARROW CVC SET; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number VASCULAR UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported that "patient with acute exacerbated copd.After 4 days of sonographic detection of a catheter-resistant thrombus with complete lumen installation.Thrombosis prophylaxis was performed with 3000 iu of certoparin.We performed the sonography as part of an active screening for zvk-associated thrombosis.It's no symptomatic thrombosis." the patient's condition was reported to be "good".It was reported the hospital screens all patients with cvcs for thrombosis with sonography.There was no report of a defect with the catheter.It was reported the catheters are left in the patient even after thrombosis has been diagnosed, until the time the cvc is no longer needed for treatment.

Event Description

Customer reported that "patient with acute exacerbated copd.After 4 days of sonographic detection of a catheter-resistant thrombus with complete lumen installation.Thrombosis prophylaxis was performed with 3000 iu of certoparin.We performed the sonography as part of an active screening for zvk-associated thrombosis.It's no symptomatic thrombosis." the patient's condition was reported to be "good".It was reported the hospital screens all patients with cvcs for thrombosis with sonography.There was no report of a defect with the catheter.It was reported the catheters are left in the patient even after thrombosis has been diagnosed, until the time the cvc is no longer needed for treatment.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported that "patient with acute exacerbated copd.After 4 days of sonographic detection of a catheter-resistant thrombus with complete lumen installation.Thrombosis prophylaxis was performed with 3000 iu of certoparin.We performed the sonography as part of an active screening for zvk-associated thrombosis.It's no symptomatic thrombosis." the patient's condition was reported to be "good".It was reported the hospital screens all patients with cvcs for thrombosis with sonography.There was no report of a defect with the catheter.It was reported the catheters are left in the patient even after thrombosis has been diagnosed, until the time the cvc is no longer needed for treatment.

Manufacturer Narrative

Qn# (b)(4).The customer returned one cvc catheter for evaluation.Visual examination revealed obvious signs of use in the form of biological ma terial on the catheter body.Dimensional analysis of the returned catheter was performed based on the potential finished good and batch identified from the sales history of the customer.The total length of the catheter body measured to be 218 mm which is within s pecifications of 207mm - 227 mm per product drawing.The catheter body outer diameter measured 2.45 mm which is within the specification of 2.39 mm-2.49 mm per catheter body product drawing.The ifu provided with the potential finished good and batch identified from sales history states "flush each lumen of catheter with sterile saline solution, to establish patency and prime lumen(s)." the returned catheter was flushed using a water-filled lab inventory syringe.No blockages or leaks were detected in the white proximal lumen.When the distal and medial lumens were flushed, slight resistance was encountered as biological material exited the lumens.Once the lumens were cleared of biological material, the distal and medial lumens flushed as expected.The ifu provided with the potential finished good and batch provides the following warnings, cautions and instructions for the user: "practitioners must be aware of complications associated with central vein catheters including but not limited to: cardiac tamponade secondary to vessel wall, atrial or ventricular perforation, pleural(i.E., pneumothorax) and mediastinal injuries, air embolism, catheter embolism, catheter occlusion, thoracic duct laceration, bacteremia, septicemia, thrombosis, inadvertent arterial puncture, nerve damage, hematoma, hemorrhage, and dysrhythmias." "clinical assessment of patient must be completed to ensure no contraindications exist e.G.Allergies.This de vice is not recommended for use in the presence of device related infections or previous/current thrombosis" "flush each lumen of catheter with sterile saline solution, to establish patency and prime lumen(s)." the customer report of a catheter thrombosis could not be confirmed through complaint investigation.Dimensional and functional testing were performed based on the potential finished good and batch identified from sales history.The returned sample passed all relevant visual and functional testing.A device history record review was performed on a potential finished good and batch from sales history with no relevant findings.Additional information was received from the customer which identified that there were no alleged deficiencies or defects with the teleflex catheter.The customer reported the complaint solely due to the occurrence of a thrombosis.The complaint was reviewed by a member of the clinical and medical affairs team, which indicated that "thrombi have been found in cvcs of competitors after switching from arrow cvcs to competitor cvcs due to supply issues." based on the customer report and the sample returned, the patient condition likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• MDR Report Key: 12132663
• MDR Text Key: 261279824
• Report Number: 3006425876-2021-00599
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.