MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"; CATHETER INTRAVASCULAR THERAP

Catalog Number CDC-42703-P1A

Device Problems Failure to Advance (2524); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information obtained from maude report (mw5082351/mdr report key (b)(4)).The report does not have any additional information or contact information.

Event Description

According to the maude report (mw5082351/mdr report key (b)(4)), the md was attempting to place a triple lumen in a critical patient when the introducer wire made a 90-degree bend and could not be advanced.A second triple lumen kit was opened and had a problem with this wire (mdr #9680794-2019-00027).The wire in the second kit was stripped.Both kits were unusable.A different product was used successfully.

Manufacturer Narrative

(b)(4).Additional information was received and the customer reported that there was no patient harm or injury.The customer returned one spring wire guide and 3-lumen cvc for evaluation.Visual examination revealed that the spring wire guide had four kinks along the guide wire body.Signs of use in the form of biological material was observed on the guide wire and catheter.Microscopic examination confirmed that both the proximal and distal welds were spherical and intact.No other defects or anomalies were observed.The guide wire length and outer diameter were measured and were found to be within specification.The kinks in the spring wire guide were located 144m, 160mm, 169mm, and 245mm from the proximal end.A straight pin gage with a diameter of.032" was passed through the distal end of the catheter to clear any blockages.No blockages were observed.After passing the straight pin gage, a guide wire with a diameter of.032" was passed through the distal end of the catheter.The guide wire was able to pass completely through the catheter with little to no resistance.A manual tug test confirmed that both the proximal and distal weld were intact and secure.A device history record review was performed with no relevant findings to suggest a manufacturing issue.The ifu provided with the kit warns the user, "do not apply excessive force in removing spring wire guide or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained, and further consultation requested".The ifu also informs, "maintain firm grip on spring-wire guide at all times." the report of "swg/cath resistance - kinked" was confirmed through complaint investigation of the returned sample.The guide wire had four kinks located at 144m, 160mm, 169mm, and 245mm from the proximal tip.The returned guide wire met all relevant dimensional requirements and a device history record review was performed with no relevant findings to suggest a manufacturing issue.Functional testing on the returned catheter did not reveal any blockages or other abnormalities.Based on the condition of the returned sample and the damage occurred during use, it was determined that unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

According to the maude report (mw5082351/mdr report key 8186089) the md was attempting to place a triple lumen in a critical patient when the introducer wire made a 90-degree bend and could not be advanced.A second triple lumen kit was opened and had a problem with this wire (mdr #9680794-2019-00027).The wire in the second kit was stripped.Both kits were unusable.A different product was used successfully.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8281357
• MDR Text Key: 134472125
• Report Number: 9680794-2019-00026
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: CDC-42703-P1A
• Device Lot Number: 13F18D0506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1