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	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "sheath reported as loose and becoming disconnected from dilator while attempting to advance.This is her 2nd time using kitting/product.While attempting to advance, she had noticed burring of the sheath.It is possible this may have been user related as her technique was alternating between clockwise twisting and counter-clockwise twisting with the introducer within the skin, but sheath remaining outside tissue.Sheath was removed without issue from guidewire, observed mushrooming from sheath peeling backward from force.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath with dilator assembly for analysis.Signs of use were observed on the returned components.Visual analysis revealed both the distal end of the dilator and sheath tip were damaged.This damage is consistent with undue force used during an attempted insertion.However, review of the peel-away sheath product drawing revealed that the returned sample does not match the peel-away sheath with dilator assembly in finished good dlx-45541-curvc.The dilator in finished good dlx-45541-curvc has a yellow hub while the returned dilator has a blue hub.Therefore, the customer either returned the wrong product or reported the wrong finished good.No other defects were observed with the returned components.The sheath length from the tabs to the distal tip measured 2 13/16", which is within the specification limits of 2 5/8"-2 7/8" per peel-away product drawing.The sheath outer diameter measured 0.095", which is not within the specification limits of 0.078"-0.084" per peel-away extrusion product drawing.The sheath inner diameter at the distal tip could not be accurately measured due to the nature of the damage.The returned dilator body length measured 3 5/8", which is within the specification limits of 3 5/8"-3 7/8" per dilator product drawing.The returned dilator outer diameter measured 0.077", which not within the specification limits of 0.063"-0.065" per dilator product drawing.The dilator was removed and reinserted back into the sheath.The dilator was able to pass through the sheath with little to no resistance.Performed per instructions-for-use (ifu) statement, "ensure dilator is in position and locked to hub of sheath.Check peel-away sheath placement by holding sheath in place, twisting dilator hub counterclockwise to release dilator hub from sheath hub".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.If necessary, enlarge cutaneous puncture site with cutting edge of scalpel, positioned away from guidewire.".The report of peel-away sheath damage during use was confirmed through complaint investigation of the returned.Visual analysis revealed that both the peel-away sheath tip and dilator tip were damaged.The appearance of the damage is consistent with damage resulting from undue force applied during an attempted insertion.However, the returned peel-away sheath with dilator assembly did not meet all dimensional requirements and the returned dilator did not match the one that comes in reported finished good dlx-45541-curvc which suggests the customer either returned the incorrect component or reported the incorrect finished good.Based on the customer report and the sample received, the root cause cannot be determined based on the discrepancy between the returned device and the reported finished good number.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.4.-unique identifier (udi)# corrected from (b)(4).
Event or Problem Description
It was reported "sheath reported as loose and becoming disconnected from dilator while attempting to advance.This is her 2nd time using kitting/product.While attempting to advance, she had noticed burring of the sheath.It is possible this may have been user related as her technique was alternating between clockwise twisting and counter-clockwise twisting with the introducer within the skin, but sheath remaining outside tissue.Sheath was removed without issue from guidewire, observed mushrooming from sheath peeling backward from force.

• 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: 19476235
• Report Number: 9680794-2024-00573
• Device Sequence Number: 4036113
• Product Code: LJS
• UDI-Device Identifier: 10801902208726
• UDI-Public: 10801902208726
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 01/31/2025
• Device Catalogue Number: DLX-45541-CURVC
• Device Lot Number: 33F24A0501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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: Female