MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-45703-PSJR

Device Problems Difficult to Insert (1316); Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information received from the risk manager at the user facility: the patient developed an iatrogenic pneumothorax on the right side following the attempted but not successful right sided subclavian central line attempt.This was treated with a chest tube that has since been removed and pneumothorax resolved.However, there was no known injury relating to the retained piece of guide wire that was successfully removed under local in out interventional radiology department.The patient came from a long term care facility as has a traumatic brain injury and is not doing well but that is also not related to this guidewire event.

Event Description

The customer reports: on (b)(6) 2020, patient underwent an emergent attempted right sided subclavian central line insertion that was not successful as physician noted unable to pass the wire despite aspiration of appropriate blood and guidewire etc.Was removed.The physician did not know a piece of the guidewire had broken off and remained in the patient and therefore the actual kit used was not saved.Intervention: through radiology imaging a foreign body was seen and on (b)(6) 2020, the patient was taken to interventional radiology.Local anesthetic was administered and through the patient's existing right internal jugular central line, the broken off guidewire piece (in the ivc that extended into the right atrium) was snared and successfully removed without any complication.

Event Description

The customer reports: on (b)(6) 2020, patient underwent an emergent attempted right sided subclavian central line insertion that was not successful as physician noted unable to pass the wire despite aspiration of appropriate blood and guidewire etc.Was removed.The physician did not know a piece of the guidewire had broken off and remained in the patient and therefore the actual kit used was not saved.Intervention: through radiology imaging a foreign body was seen and on (b)(6) 2020, the patient was taken to interventional radiology.Local anesthetic was administered and through the patient's existing right internal jugular central line, the broken off guidewire piece (in the ivc that extended into the right atrium) was snared and successfully removed without any complication.

Manufacturer Narrative

(b)(4).The customer returned a portion of guide wire for evaluation.The proximal end of the guide wire was not returned for analysis.Visual examination of the presumed distal end revealed the coil wire was separated about halfway down the body.The distal weld appeared full and spherical.After the guide wire failed the manual tug test, the distal end of the returned wire was expanded.Microscopic examination revealed the core wire was separated directly adjacent to the distal weld.A small portion of flattened core wire was observed connected to the distal weld.Visual examination of the remaining portion of guide wire could not be performed as it was not returned for analysis.The length of the returned guide wire could not be measured as no core wire was present and the coils were unraveled and lengthened.The outer diameter of the guide wire measured to be 0.788 mm which is within specifications of 0.788-0.826 mm per product drawing.Dimensional inspection of the remaining portion of guide wire could not be performed as it was not returned for analysis.Functional inspection could not be performed due to the damage of the guide wire.A manual tug test was performed which revealed the distal weld was not secured to the core wire.Further examination confirmed the core wire was separated adjacent to the distal weld.Additional testing of the remaining portion of guide wire could not be performed as it was not returned for analysis.The instructions-for-use (ifu) provided with this kit warns the user, "do not withdraw guidewire against needle bevel to minimize the risk of possible severing or damaging of guidewire." the ifu also warns, "do not apply undue force on guidewire to minimize the risk of possible breakage." the customer report of a guide wire separation was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld and the coil wires were separated approximately halfway down the guide wire body.Dimensional inspection did not reveal any evidence of a manufacturing related issue.A device history record review could not be performed as a valid lot was not provided by the customer and a potential lot could not be determined from a sales history review for this customer.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire separation could not be determined based upon the information provided and without the remaining portion of guide wire being returned.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9700133
• MDR Text Key: 188214938
• Report Number: 1036844-2020-00038
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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 Operator: Health Professional
• Device Catalogue Number: ASK-45703-PSJR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention