MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN030691

Device Problem Obstruction of Flow (2423)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 08/28/2023

Event Type  Injury  

Event Description

It was reported that "a patient with a femoral cvc needed several additional medications via different cvc lumens as a bolus due to his haemodynamics and intracranial pressure therapy.It was noticed that any bolus (no matter which medication, e.G.Painkillers, sleeping pills) caused a strong increase in blood pressure.Norepinephrine ran continuously at about 30mcg.The patient also showed the same condition with every short infusion, with massive hypertension for a short time.After changing the cvc, this problem was no longer observed".It was reported "therapy goals (target values for blood pressure and intracranial pressure) could not be met".Additional information was requested but not available at the time of this report.

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one, 4-lumen cvc for analysis.Signs of use were observed in the second medial line as there was residual fluid inside the lumen.Visual analysis revealed that the catheter body contained a deformation along the length of the body towards the proximal end near the juncture hub.Microscopic examination confirmed the damage and revealed indentations on either end of the body.The observed kink in the catheter body was measured at 15mm from the juncture hub.The overall length of the catheter measured at 215mm which is within the specification limits of 207-227mm per product drawing.The catheter outer diameter measured at 2.86mm which is within the specification limits of 2.85-2.95mm per product drawing.The catheter was functionally tested per the instructions per use provided with this kit, which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all four extension lines were flushed using a lab inventory syringe and flushed as intended.No blockages or resistance were identified.A lab inventory guide wire with a diameter of 0.032" was inserted through the catheter.Minor resistance was encountered at the location of the kink; however, the pin gauge was still able to pass through the catheter out to the ski ve hole.This was repeated with the three remaining extension lines with no resistance encountered.It appears that the kink observed in the catheter body, although it did not obstruct fluid flow, could have caused some resistance during use.Quality engineering from the manufacturing/packaging site for this product was consulted for further analysis.They indicated that the observed defect could occur during the packaging of the kitted device.The appearance and location of the damage are consistent with the catheter body becoming pinched by the cup that is placed over the catheter within the kit packaging.For this damage to occur, the catheter could have either been misplaced within the tray or shifted out of the tray location during shipping/storage.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s).Check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed.Flush lumen(s) to completely clear blood from catheter." the customer report of a kinked catheter body was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the catheter body was kinked/flattened adjacent to the juncture hub.Dimensional and functional analysis of the catheter did not reveal any manufacturing/extrusion related issues.However, the appearance and location of the damage is consistent with the catheter body becoming pinched by the cup that is placed over the catheter within the kit packaging.For this damage to occur, the catheter could have either been misplaced within the tray or shifted out of the tray location during shipping/storage.Based on these circumstances, the probable root cause is packaging related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "a patient with a femoral cvc needed several additional medications via different cvc lumens as a bolus due to his haemodynamics and intracranial pressure therapy.It was noticed that any bolus (no matter which medication, e.G.Painkillers, sleeping pills) caused a strong increase in blood pressure.Norepinephrine ran continuously at about 30mcg.The patient also showed the same condition with every short infusion, with massive hypertension for a short time.After changing the cvc, this problem was no longer observed".It was reported "therapy goals (target values for blood pressure and intracranial pressure) could not be met".Additional information was requested but not available at the time of this report.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17797665
• MDR Text Key: 324013189
• Report Number: 3006425876-2023-00916
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN030691
• Device Catalogue Number: CH-45854-USZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/20/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention