MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18 GA X 6-1/2IN; CATHETER, PERCUTANEOUS

Catalog Number	ASK-01618-CHUM
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Difficult to Advance (2920)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "guide wire is too short, too stiff to do not slip into the vessel"."the patient did get a big hematoma, unable to place the line." additional information reports there was scar tissue present prior to insertion.The hematoma required manual compression.The patient's current condition is reported as "fine, no nerve damage".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one opened arterial catheterization kit for analysis, including one guide wire assembly, needle, and catheter.The customer stated that the returned kit was a representative sample.No definite signs of use were observed.Visual analysis of the guide wire revealed slight kinking, but the customer was not aware of any guide wire damage.Therefore, the kinking was not investigated as part of this investigation.Despite this, no obvious defects or anomalies were observed.Visual analysis of the reported kit could not be confirmed as it was not returned for analysis.The guide wire length measured 455mm, which is within the specification limits of 450-458mm per the guide wire product drawing.The guide wire outer diameter measured 0.611mm, which is within the specification limits of 0.61-0.635mm per the guide wire product drawing.The guide wire was inserted through the returned introducer needle.The guide wire was able to pass with little to no resistance.Performed per ifu statement, "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." a manual tug test confirmed that both welds were secure and intact.A device history record review was performed and no relevant findings were identified.The ifu provided with the reported kit informs the user, "precaution: do not advance guidewire unless there is free blood flashback.Precaution: maintain firm grip on guidewire at all times".The customer report of a guide wire that is difficult to advance was not able to be confirmed through investigation of the returned representative sample.The returned guide wire passed all relevant visual , dimensional, and functional requirements.Testing of the actual device from the customer reported event could not be performed as it was not returned for evaluation.The guide wire module requirement states that the guide wire is designed with a core and coil wire, of which the core wire provides strength and rigidity.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.Therefore, based on the customer report and without the reported sample returned for analysis, the potential root cause could not be determined.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "guide wire is too short, too stiff to do not slip into the vessel"."the patient did get a big hematoma, unable to place the line." additional information reports there was scar tissue present prior to insertion.The hematoma required manual compression.The patient's current condition is reported as "fine, no nerve damage".

• Brand Name: ARROW ARTERIAL CATH SET: 18 GA X 6-1/2IN
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 20523954
• Report Number: 9680794-2024-01056
• Device Sequence Number: 12782016
• Product Code: DQY
• UDI-Device Identifier: 10801902111965
• UDI-Public: (01)10801902111965(11)230620(17)270731(10)33F23F0201(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093050
• 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): 10/02/2024

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
• Device Catalogue Number: ASK-01618-CHUM
• Device Lot Number: 33F23F0201
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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