MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-34052-HPHNM
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the peel away sheath dilator bifurcation".A new set was opened to resolve the issue.The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one peel-away with dilator assembly and a lidstock for analysis.Signs of use were observed inside the sheath extrusion.Visual analysis revealed that the distal end of the sheath tip was folded inward and damaged.The peel-away sheath was also cross-sectioned.No defects were observed with the dilator.The sheath length from the tabs to the tip measured 4" , which is within the specification limits of 3 7/8"-4 1/8" per the peel-away product drawing.The sheath outer diameter measured 0.095", which is within the specification limits of 0.093"-0.099" per the 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 sheath was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "check peel-away sheath placement by holding sheath in place , twisting dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow.Holding sheath in place, remove guidewire and dilator as a unit." the dilator was removed and reinserted back into the sheath.The dilator was able to pass through the sheath tip with little to no resistance.The dilator hub was additionally able to lock into the sheath hub as intended.R & d and mfg were consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user.Due to the possibility that manufacturing contributed to this damage, they will further investigate this issue.A device history record review was performed, and findings were identified.Three non-conformances were initiated for batch 34c23d0085 to address the issue of "peel-away sheath tears incorrectly".The ifu provided with the kit informs the user, "do not withdraw dilator until sheath is well within vessel to reduce risk of damage to sheath tip".The ifu also states, "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 a peel-away tip damage was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was damaged/deformed.Despite the damage, the sheath met all relevant dimensional and functional requirements.Various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user, therefore, the root cause could not be confirmed.A non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the peel away sheath dilator bifurcation".A new set was opened to resolve the issue.The patient had no harm or injury.

• Brand Name: ARROW PI PICC 2L 5FRX40CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 21396940
• Report Number: 9680794-2025-00151
• Device Sequence Number: 9199566
• Product Code: LJS
• UDI-Device Identifier: 00801902100979
• UDI-Public: (01)00801902100979(11)230619(17)250531(10)33F23C0667(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K113277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 05/31/2025
• Device Catalogue Number: PR-34052-HPHNM
• Device Lot Number: 33F23C0667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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: Unknown