MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "twisted catheter noticed when over wire for a new catheter because line was pulled out slightly." a chest xray was obtained to determine the picc tip location.The picc line was removed and replaced.It was reported "the patient remained stable and had a new picc replaced by our team on (b)(6) 2024.The patient then discharged from the hospital on (b)(6) 2024.".
Event or Problem Description
It was reported "twisted catheter noticed when over wire for a new catheter because line was pulled out slightly." a chest xray was obtained to determine the picc tip location.The picc line was removed and replaced.It was reported "the patient remained stable and had a new picc replaced by our team on (b)(6) 2024.The patient then discharged from the hospital on (b)(6) 2024.".
Additional Manufacturer Narrative
(b)(4).The customer provided three photos for analysis.One photo indicates the catheter was placed on (b)(6) 2024, which is three (3) days prior to the catheter defect being observed.The customer also returned one, 2- lumen picc for analysis.Signs of use were observed on the catheter body.Visual analysis revealed the catheter body had multiple kinks towards the center of the body.The locations of the kink also appeared stretched.The distal end of the catheter appeared to be intentionally severed and was not returned.The kinked portion of the catheter body measured approximately 80 mm - 120 mm from the juncture hub.The length of the catheter body measured 31.70 cm, which is not within the specification limits of 55.86-57.77 cm per catheter product drawing; therefore, at least 24.16 cm of the catheter was severed and not returned.The outer diameter of the catheter body measured 0.073", which is within the specification limits of 0.069"-0.074" per catheter product drawing and catheter extrusion product drawing.The catheter was functionally tested per the instructions-for-use (ifu) provided with this kit which instructs the user, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture." each lumen was flushed using a lab inventory syringe filled with water and each lumen flushed as intended without signs of leaks or blockages.Additional information from the customer stated, "reports from the bedside staff are that the line appeared to be longer than it should have been, outside the dressing on (b)(6) 2024 (night shift).They believed it may have been pulled on or gotten caught on something." the customer photo indicates the catheter was placed on (b)(6) 2024, which indicates the catheter was in the patient three days prior to the catheter defect being observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs 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." the customer report of a kinked catheter was confirmed through complaint investigation of the returned sample.The returned catheter body was kinked and stretched towards the center of the body.Despite this , the catheter passed all relevant functional requirements.Additional information from the customer suggests the catheter was in the patient three days prior to the catheter defect being observed.Based on these circumstances, it is probable the catheter experienced a pulling force resulting in the damage observed; therefore, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 1L 4.5FR 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: 20385375
• Report Number: 9680794-2024-00984
• Device Sequence Number: 6473162
• Product Code: LJS
• UDI-Device Identifier: 10801902208733
• UDI-Public: (01)10801902208733(11)240518(17)251210(10)33F24C0874(21)
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 12/10/2025
• Device Catalogue Number: DLX-45552-CURVC
• Device Lot Number: 33F24C0874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2024
• 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
• Patient Sex: Unknown