MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI; CATHETER INTRAVASCULAR THERAPE

Model Number IPN036491

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint received reports: "the tip of a guidewire from your product broke off during a vascath insertion." additional information received 19sep2022 reports: "the piece that broke from the tip infiltrated into the patient's heart requiring immediate intervention utilizing interventional radiology.The patient was stable post procedure.".

Manufacturer Narrative

(b)(4).The customer provided one image showing a portion of the kit lidstock for analysis.The lot# matches the customer report.The customer also returned one defective guide wire for analysis.No definite signs of use were observed.Visual analysis revealed that the guide wire was unraveled from the distal end.One major kink and one large continuous bend were also observed towards the proximal end.The damage resulted in the distal j-bend to be slightly misshapen.Microscopic examination confirmed the damage and revealed that the distal weld had detached from both the core and coil wires but was not returned.It was also noted that the proximal weld was spherical and intact.Visual analysis could not be performed on the distal weld to confirm the nature of the separation as it was not returned for analysis.The major kink in the guide wire measured 21mm from the proximal weld.The guide wire total length (from proximal weld to the point of separation on core wire) measured 602mm , which is within the specification limits of 596mm-604mm per the guide wire product drawing.The guide wire outer diameter measured.84mm, which is within the specification limits of.838mm-.877mm per the guide wire product drawing.A manual tug test confirmed that the proximal weld was secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report of a separated guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was severely unraveled towards the distal end.Microscopic analysis further revealed that the distal weld had become separated from both the core and coil wire and was not returned for analysis.Despite this, the guide wire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.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, the appearance of the damage seems consistent with damage due to undue force; however, this cannot be confirmed without the separated distal weld also returned to confirm the nature of the separation.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer complaint received reports: "the tip of a guidewire from your product broke off during a vascath insertion".Additional information received 19sep2022 reports: "the piece that broke from the tip infiltrated into the patient's heart requiring immediate intervention utilizing interventional radiology.The patient was stable post procedure".

• Brand Name: ARROW LBCVC KIT: 3-L 12 FR X 16 CM ANTIMICROBI
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15555358
• MDR Text Key: 301332395
• Report Number: 9680794-2022-00626
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 50801902116845
• UDI-Public: 50801902116845
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/31/2023
• Device Model Number: IPN036491
• Device Catalogue Number: CDC-22123-1A
• Device Lot Number: 13F21L0383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• 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
• Patient Outcome(s): Required Intervention