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

Catalog Number	DLX-45541-CURVC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "" during picc insertion, inserter met resistance as catheter inserted.Maneuvering techniques were used to advance the picc unsuccessfully.The stylet wire was attempted to be removed and resistance met.Wire was fully retrieved and noted to be bent.Stylet wire exchanged with new accessory wire and picc unable to be advanced.Inserter then tried to remove picc and was unable remove.Picc could not be flushed however wire could be removed.As the peel away sheath was broken and removed the picc catheter finally gave way and could be removed." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr number include 9680794-2024-00092 and 9680794-2024-00155.
Additional Manufacturer Narrative
(b)(4).The customer returned one catheter and peel away sheath for analysis.The peel away sheath was returned threaded over the catheter.Definite signs of use were observed.The peel away sheath was removed from the catheter to further analyze the component.Visual analysis revealed that the tip of the peel away sheath was folded inward.It was also noted that the sheath extrusion was partially torn down both score lines as intended.Despite the folding at the tip, the overall length of the peel away sheath measured 2 11/16" which is within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The outer diameter of the sheath measured 0.0795" which is within the specification limits of 0.078 - 0.084" per the sheath extrusion drawing.The catheter was additionally advanced through the intact portion of the returned peel away sheath.The entire catheter was able to pass through the sheath with little to no resistance.Performed per ifu statement, "insert catheter through peel-away sheath to final indwelling position." r & d and the manufacturing facility were consulted and stated that 100% inspections are performed during assembly that would detect this defect.R & d proposed multiple potential causes for the damage.They stated that during manufacturing, the sheath tip could get stuck on the tipping pin and became inverted when removed, but this would likely be identified by the tipping or assembly operator.There are also both functional and visual inspections performed as part of the sheath/dilator assembly process that should have identified the inverted tip if it happened at, or prior to, assembly.Alternatively, r & d stated that it's possible this kind of damage could be a result of the sheath tip being pulled/pushed over another component as observed.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage.".The ifu also stated, "precaution: do not withdraw dilator until sheath is well within vessel to reduce risk of damage to sheath tip." the customer report of a sheath body damage was confirmed through investigation of the returned sample.The sheath tip was folded inward.Despite this, the sheath passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report, the sample received, and comments from r & d and manufacturing, it was determined that unintentional user error likely 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18867887
• Report Number: 9680794-2024-00264
• Device Sequence Number: 14205494
• Product Code: LJS
• UDI-Device Identifier: 10801902208726
• UDI-Public: 10801902208726
• 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
• Report Date (Section B): 02/26/2024

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: 01/24/2025
• Device Catalogue Number: DLX-45541-CURVC
• Device Lot Number: 33F23G0488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2023
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown