MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 22GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-00822-PBX
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2026, in the operating theatre, we had an issue with a sac-00822-pbx arterial catheter.The introducer guide bent, requiring the use of another one." a second device was used to complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire and a lidstock for evaluation.Signs of use in the form of biological material were observed on the guidewire.Visual analysis revealed one kink in the guidewire body.Microscopic examination confirmed that both welds were secure and intact.The kink on the guidewire was located 224 mm from the first weld.The guidewire length measured 351 mm, which is within the specification limits of 345 mm - 355 mm per guidewire product drawing.The guidewire outer diameter measured 0.510 mm, which is within the specification limits of 0.508 mm - 0.533 mm per guidewire product drawing.The guidewire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." the guidewire was advanced through a lab inventory 22 ga introducer needle.The undamaged portions of the guidewire passed with no resistance.A manual tug test confirmed that the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user , "precaution: use care when removing guidewire.If resistance is encountered, remove guidewire and catheter together as a unit.Use of excessive force may damage catheter or guidewire." the customer report of a kinked guidewire was confirmed through investigation of the returned sample.One kink was observed on the guidewire body.Despite the damage, the guidewire met all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on observed damaged and the customer report that the defect occurred during use , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on 19 january 2026, in the operating theatre, we had an issue with a sac-00822-pbx arterial catheter.The introducer guide bent, requiring the use of another one." a second device was used to complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW ARTERIAL CATH SET: 22GA X 8CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24313931
• Report Number: 3006425876-2026-00160
• Device Sequence Number: 5650162
• Product Code: DQY
• UDI-Device Identifier: 10801902129915
• UDI-Public: (01)10801902129915(11)251015(17)300930(10)71F25K0389(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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 Catalogue Number: SAC-00822-PBX
• Device Lot Number: 71F25K0389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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