MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 20 GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number	SAC-00820
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the guide wire was found bent/kinked prior to use on patient.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, opened sac set for evaluation.The returned packaging had signs of folding/creasing upon return.The protective tubing was not returned.Visual analysis revealed one kink on the guide wire body.The lidstock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.The kink on the guide wire measured 145 mm (ruler: (b)(4)) from the distal tip.The guide wire length measured 349 mm, which is within the specification limits of 345-355 mm per guide wire product drawing.The guide wire outer diameter measured 0.510 mm, which is within the specification limits of 0.508-0.533 mm per guide wire product drawing.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "thread tip of catheter over guidewire.Precaution: allow sufficient guidewire length to remain exposed at hub end of catheter to maintain firm grip on guidewire.Grasping near skin, advance catheter into vessel." the guide wire was advanced through the returned catheter and the undamaged portions were able to pass with little to no resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not use if package is damaged".The lidstock label for finished good sac-00820 rev.44 was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.The customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.The returned packaging had signs of folding/creasing upon return.One kink was observed on the guide wire body.Despite this, the guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.The product lidstock clearly states, "do not bend." based on the customer description and the sample received, storage and shipping 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: "the guide wire was found bent/kinked prior to use on patient.".

• Brand Name: ARROW ARTERIAL CATH SET: 20 GA 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: 20609850
• Report Number: 3006425876-2024-01048
• Device Sequence Number: 15435923
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: (01)10801902144079(11)230505(17)280430(10)71F23E0003(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093050
• 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): 10/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F23E0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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