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

Catalog Number	DLX-45552-CURVB
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the sheath in the kit was not smooth.There was a ripple long the edge of the sheath (described as a "spur").The physician did not advance it all the way into the patient so as not to cause trauma.The case was completed successfully and there was no reported harm to the patient.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the sheath in the kit was not smooth.There was a ripple long the edge of the sheath (described as a "spur").The physician did not advance it all the way into the patient so as not to cause trauma.The case was completed successfully and there was no reported harm to the patient.
Additional Manufacturer Narrative
(b)(4), the customer returned one peel-away catheter body analysis.No definite signs of use were observed; however, the peel-away was completely split down the seam lines.Visual examination revealed that one half of the sheath body contained an indentation around the middle of the extrusion.The sheath body appeared folded at the locations of the damage.No defects or anomalies were observed on the other half of the extrusion.The damage on the sheath measured approximately 13mm from the tabs.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 product drawing.The outer and inner diameters of the sheath body could not be accurately measured as the peel-away was already split completely down the seam lines.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 the 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.A section of the sheath body was found to be deformed and folded.The sample passed all relevant dimensional inspections, and a device history record review was performed with no relevant findings.Based on the appearance of the damage, the customer report that the defect was observed during use, and the comments from manufacturing, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP
• 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: 17595572
• Report Number: 9680794-2023-00595
• Device Sequence Number: 7420800
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: 10801902208702
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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: 03/31/2024
• Device Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 33F23B0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Female