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	Insufficient Information (4580)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).
Event or Problem Description
It was reported "the hcp found guidewire has a kink during use on patient." there was no medical interventions required.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4) the customer returned one, opened sac kit including one guide wire within the catheter and protective tubing for analysis.The introducer needle was not returned.Signs of use were observed on the guide wire.Visual analysis revealed the protective tubing had one kink towards the distal end of the body which aligned with a kink on the guide wire.The lidstock clearly states, "do not bend." the damage observed is consistent with defects related to storage and shipping with contradicts the customer report that the damage was observed during use.The guide wire was observed to have another kink towards the proximal end of the body.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The kinks in the guide wire were located 99 mm and 265 mm from the distal tip.The overall length of the guide wire measured 349 mm, which is within the specification limits of 345-355 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.515 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, "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle).At this point, the depth-marking entering hub shows that tip of wire leaves tip of introducer needle and enters vessel." the guide wire was advanced through a lab inventory 20ga introducer needle to functionally test the guide wire.The undamaged portions of the guide wire passed through with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "precaution: do not advance guidewire unless there is free blood flashback.Precaution: always maintain firm grip on guidewire.Pre-caution: 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 lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had two kinks on the guide wire body.One kink aligned with a kink in the protective tubing.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing related issues.The packaging clearly states, "do not bend." based on the condition of the sample, the damage on the guide wire and protective tubing is consistent with damage that occurs during storage and shipping.However, since the customer reported the defect was observed during use, it cannot be determined when the damage to the guide wire occurred.Therefore, the root cause cannot be determined based on the information provided and the sample received.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the hcp found guidewire has a kink during use on patient." there was no medical interventions required.The patient's current condition is reported as "unknown".

• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19702768
• Report Number: 3006425876-2024-00693
• Device Sequence Number: 17047986
• Product Code: DQY
• UDI-Device Identifier: 10801902144079
• UDI-Public: (01)10801902144079(11)230411(17)280331(10)71F23D0009(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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 71F23D0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown