MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-45703-AKP1A

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

Customer complaint reports: the pa reported no issues placing the line.The wire went in smoothly and came out smoothly.The post-procedure chest x-ray showed retained wire in the ra.The pa found the wire and it appeared that it uncoiled and broke off inside the patient.The patient needed to be transferred to a tertiary care center for possible ir intervention for removal.Additional information was requested but was not available at the time of this report.

Manufacturer Narrative

(b)(4).Additional information received 18-sep-2023 indicates the patient "remains critically ill due to multiple medical conditions both acute and chronic" and that there was no evidence of harm or injury.It was also reported that "pt was transferred from our hospital (community hospital) to tertiary care center for removal of retained guidewire.Ir utilized fluoroscopy and snare to remove guidewire in its entirety." the actual device was not returned; however, the customer provided two photos for analysis.The complaint of guidewire separated during use was able to be confirmed by the photos and customer report.Both photos revealed x-ray images of the patient with a retained foreign body in the vascular system, however, no conclusions about the cause of the damage could be made from the photos alone.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history with one finding.It was determined that the finding is not relevant to the reported complaint issue.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.1.-brand name corrected to arrow multilumen pi cvc kit: 3l 7 fr x 20 cm section d.2.-catalog# corrected to ask-45703-akp1a.

Event Description

Customer complaint reports: the pa reported no issues placing the line.The wire went in smoothly and came out smoothly.The post-procedure chest x-ray showed retained wire in the ra.The pa found the wire and it appeared that it uncoiled and broke off inside the patient.The patient needed to be transferred to a tertiary care center for possible ir intervention for removal.

• Brand Name: ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 17756757
• MDR Text Key: 323517927
• Report Number: 9680794-2023-00653
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 30801902119644
• UDI-Public: 30801902119644
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/21/2023

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 Operator: Health Professional
• Device Catalogue Number: ASK-45703-AKP1A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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