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 Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "sheath over dilator buckled.Inserter placed dilator/sheath over the guidewire to place into patient.Sheath pushed back (buckled).The patient was reported to have tough skin.Clinician advised remove sheath from dilator and dilate skin first in c circumstances w/ tough skin.Clinician believes this could be a faulty sheath." no medical intervention required.No patient injury or consequence.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for analysis.Definite signs of use were observed.Visual examination revealed that the distal tip of the sheath was crimped/folded.Slight creasing of the sheath body was additionally observed.The appearance of the damage is consistent with undue force applied unintentionally during insertion.The total length of the sheath body measured to be 2 3/4", which is within the specifications of 2 5/8" - 2 7/8" per sheath product drawing.The outer diameter of the sheath measured 0.08325" which is within the specification limits of 0.078" - 0.084" per sheath extrusion drawing.The sheath was functionally tested per the instructions for use (ifu) provided with this kit , which instructs the user, "ensure dilator is in position and locked to hub of sheath." a lab inventory dilator was removed and reinserted through the sheath and passed with little to no resistance.The dilator hub was also able to successfully lock into the sheath hub.Manufacturing has been previously contacted regarding this failure mode.They perform a dimensional inspection report on these peel-away sheath extrusion and have found no evidence to suggest a manufacturing related issue.A device history record review was performed, and no relevant findings were identified.The 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 customer report of a damaged sheath was confirmed by complaint investigation of the returned sample.The tip appeared folded or crimped.The sample passed all relevant dimensional and functional inspections , and a device history record review was performed with no relevant findings.Based on the appearance of the damage and the customer report that the defect was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "sheath over dilator buckled.Inserter placed dilator/sheath over the guidewire to place into patient.Sheath pushed back (buckled).The patient was reported to have tough skin.Clinician advised remove sheath from dilator and dilate skin first in circumstances w/ tough skin.Clinician believes this could be a faulty sheath." no medical intervention required.No patient injury or consequence.The patient's current condition is reported as "fine".

• 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: 18730746
• Report Number: 9680794-2024-00214
• Device Sequence Number: 17906268
• Product Code: LJS
• UDI-Device Identifier: 10801902208726
• UDI-Public: 10801902208726
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/25/2024

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
• Operator of Device: Health Professional
• 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: 02/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown