MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number IPN918714

Device Problem Device Slipped (1584)

Patient Problems Arrhythmia (1721); Insufficient Information (4580)

Event Date 09/03/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: the catheter slips through the clamp when wet.Additional information has been requested from the account.

Manufacturer Narrative

(b)(4).Additional information states that the device migration caused arrhythmia and unstable blood pressure.A new device was placed.The patients current condition was not reported.The customer returned one opened cvc kit, including one catheter, box clamp, and guide wire assembly, for analysis.No definite signs of use were observed.Visual analysis of the catheter revealed that the box clamp assembly was returned and attached to the catheter body.The box clamp was attached towards the juncture hub of the catheter extrusion.No damage, defects or anomalies were observed with the catheter or box clamp.The catheter box clamp was observed to be present towards the juncture hub of the catheter.Based on the customer description, it cannot be determined if the catheter was secured via sutures to the catheter body juncture hub (primary site) or the box clamp (secondary site) or both.It was also noted that the guide wire contained a slight bend.Additional clarification was requested of the customer regarding the damage, and no additional information was received.The overall length of the catheter measured 222mm which is within the specification limits of 207mm - 227mm per the catheter product drawing.The catheter outer diameter measured 2.935mm which is within the specifications of 2.87mm - 2.97mm per both catheter extrusion product drawing.The clamp catheter inner diameter measured 0.108", which is within the specifications of 0.108" - 0.116" per the catheter product drawing.The inner diameter of the clamp fastener measured 0.174", which is within the specification limits of 0.167" - 0.177" per the clamp fastener product drawing.Functional inspection was performed per the instructions for use (ifu)provided with this kit which states, "use a catheter stabilization device, catheter clamp and fastener, staples or sutures (where provided) use catheter hub as primary securement site use catheter clamp and fastener as a secondary securement site as necessary".The box clamp was attached to the catheter body.To test the axial clamp holding force, the box clamp assembly was then attached to a force gauge.Per amrq-000145 rev04, generation 1 combinations of the clamp/fastener for catheters up to 7fr should sustain a withdrawal force of = 2n (0.44 lbs).The box clamp assembly was pulled in direction of the catheter body to 0.44 lbs.No movement of the clamp was observed.Therefore, the customer report could not be confirmed.R & d was contacted as a part of this complaint investigation.They stated that bo th 4-lumen blue catheter clamp (k-25854-003a) and the 3-lumen white catheter clamp (k-14703-013a) are made of the same material.They are made of styrene butadiene which is a type of thermoplastic elastomer.The clamp fastener is composed of a different material but is included within all kits.Additionally, as per the ifu, they confirmed that the components should be used with a dry catheter.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user, "after guidewire has been removed and necessary lines have been connected or locked, spread wings of rubber clamp and position on catheter making sure catheter is not moist, as required, to maintain proper tip location." the customer report of a catheter migration could not be confirmed through complaint investigation of the returned sample.Based on the customer description, no determination could be made about whether the catheter was secured using primary, secondary or both securement sites.Functional testing of the returned device could not reproduce the reported failure mode.R & d was contacted, and they confirmed that the catheter body is intended to be dry as per the ifu.Based on the functional testing of the returned device and feedback from r & d, the probable cause could not be determined at this time without specific details of how the catheter was secured during use.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: the catheter slips through the clamp when wet.

• Brand Name: CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 17985171
• MDR Text Key: 326267286
• Report Number: 3006425876-2023-01003
• Device Sequence Number: 1
• Product Code: DQY
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN918714
• Device Catalogue Number: EU-15854-CVT
• Device Lot Number: 71F22G2634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Female