MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVC
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " right brachial vein accessed just above antecubital vein.Picc threaded without difficulty.Discrepancy of 10 cm between external measuremend required a chest x- ray to verify tip position.Cxr was taken and radiologist said line appeared to be mid-svc.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#: (b)(4).Udi number: (b)(4).
Additional Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be performed as no sample was returned for analysis.The customer provided one photograph showing the line placement confirmation and line released for use report.The second photograph provided with the complaint is a photograph of an x-ray showing the line placement.A review of the x-ray revealed "it appears the picc is in the lower third of the svc and appropriate".The customer provided a video of the case.A review of the case did not reveal any indications of improper system performance that would have led to an improper placement.The reported complaint "catheter tip location incorrect" cannot be confirmed based upon the information provided and without a sample.Complaint verification testing could not be performed.A device history record review performed on the stylet did not reveal any manufacturing related issues.A visual inspection of the product involved in the complaint could not be performed as no sample was returned for analysis.Without the device to evaluate, a probable cause could not be determined from the available information.If the sample becomes available or additional information is received, this investigation will be updated with the evaluation results.No further actions are required at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported " right brachial vein accessed just above antecubital vein.Picc threaded without difficulty.Discrepancy of 10 cm between external measuremend required a chest x- ray to verify tip position.Cxr was taken and radiologist said line appeared to be mid-svc.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).One vps rhythm dlx k-01352-001 stylet navigation stylet:.018" x 30-25/32" lg was returned.A visual examination revealed the stylet is bent at the intended flexure point with no obvious external defects or anomalies.It was reported "picc threaded without difficulty and acceptable pictures obtained.Discrepancy of 10 cm between external measurement required a chest x-ray to verify tip position.Cxr was taken and radiologist said line appeared to be mid-svc." a review of the x-ray provided by the customer revealed "it appears the picc is in the lower third of the svc and appropriate".A review of the case video did not reveal any indications of improper system performance that would have led to an improper placement.The returned stylet was functionally tested with the stylet tip submerged in a saline solution and using a known good rhy dlx system.During the testing, a good connection with the remote control was achieved, a good navigation trace was achieved, and a steady internal ecg signal with no noise or artifact was displayed.The no connection icon and the no iv icon displayed as intended.No problem was found with the functionality of the returned stylet.A device history record review performed on the stylet did not reveal any manufacturing related issues.The reported issue was not confirmed during evaluation of the returned vps rhythm dlx k-01352-001 stylet navigation stylet:.018" x 30-25/32" lg.A visual examination revealed the stylet is bent at the intended flexure point with no obvious external defects or anomalies.A probable cause for this event cannot be established since no problem was found with the functionality of the returned stylet.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "right brachial vein accessed just above antecubital vein.Picc threaded without difficulty.Discrepancy of 10 cm between external measurement required a chest x- ray to verify tip position.Cxr was taken and radiologist said line appeared to be mid-svc.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 19704990
• Report Number: 9680794-2024-00660
• Device Sequence Number: 14365914
• Product Code: LJS
• UDI-Device Identifier: 10801902208733
• UDI-Public: (01)10801902208733(11)240410(17)250917(10)33F24B0526(21)
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/17/2025
• Device Catalogue Number: DLX-45552-CURVC
• Device Lot Number: 33F24B0526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 10/25/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/09/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown