MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number	CDC-41541-MPKC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "customer states peel-away sheath over dilator is cracked at base of peel-away portion.There is a visible split down the dark blue line on the sheath.There is noticeable separation in the transition from sheath to dilator.Customer found difficulty inserting and stopped procedure upon noticing the damage.She then used a single sterile sheath to complete the procedure.She reported she has seen a total of 4 damaged sheaths from this lot number".The patient had no harm or injury.The associated emdr report numbers are 9680794-2025-00073, 9680794-2025-00072, 9680794-2025-00071, 9680794-2025-00070 and 9680794-2025-00069.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "customer states peel-away sheath over dilator is cracked at base of peel-away portion.There is a visible split down the dark blue line on the sheath.There is noticeable separation in the transition from sheath to dilator.Customer found difficulty inserting and stopped procedure upon noticing the damage.She then used a single sterile sheath to complete the procedure.She reported she has seen a total of 4 damaged sheaths from this lot number".The patient had no harm or injury.The associated emdr report numbers are 9680794-2025-00073, 9680794-2025-00072, 9680794-2025-00071, 9680794-2025-00070 and 9680794-2025-00069.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one peel-away sheath with dilator assembly for analysis.Signs of use were observed on the sheath and dilator.Visual analysis revealed that the sheath tip was damaged and partially torn at one score line.No defects were observed with the dilator.The sheath body was severed to additionally observe the cross section.The sheath outer diameter measured 0.0815", which is within the specification limits of 0.080-0.084" per peel-away product drawing.The sheath inner diameter at the distal tip and sheath length could not be accurately measured due to the nature of the damage.The peel-away sheath and dilator were functionally tested per the product instructions for use (ifu).The ifu provided as a part of this kit instructs the user, "ensure dilator is in position and locked to hub of sheath." the dilator was removed, reinserted back into the sheath, and locked into the sheath hub.The dilator was able to pass through the sheath tip with little to no resistance.R & d and manufacturing were previously 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 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 report of peel-away sheath tearing prematurely was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was damaged and partially torn at the score line.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 is undetermined.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.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• 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: 21240821
• Report Number: 9680794-2025-00073
• Device Sequence Number: 3664009
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: (01)10801902205435(11)240906(17)260611(10)33F24F0167(21)
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• 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): 01/09/2025

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: 06/11/2026
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F24F0167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown