MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number	AK-11142-SPCS
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "insertion went smoothly.Ultrasound showed catheter was in correct position in lower right atrium.Went to pull back wire and about 2/3 of the way the catheter snagged and it got stuck.They pulled back the whole unit together and saw the end of the wire at the j loop was curled and had unraveled at the end.Wire was intact though, no pieces fell off." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "insertion went smoothly.Ultrasound showed catheter was in correct position in lower right atrium.Went to pull back wire and about 2/3 of the way the catheter snagged and it got stuck.They pulled back the whole unit together and saw the end of the wire at the j loop was curled and had unraveled at the end.Wire was intact though, no pieces fell off." 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 a sheath extension assembly and a guide wire for analysis.The guide wire was advanced through the sheath extension assembly and was unraveled.The dilator was not within the sheath extension assembly and was not returned.Signs of use were observed on and within the components.Visual examination revealed the guide wire was unraveled from the distal weld and is bent along the body.The core wire distal j-bend was exposed out of the coil wire.No obvious defects or anomalies were observed on the sheath extension assembly.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was tapered at the point of separation.Both welds were present and appeared full and spherical.The guide wire was removed from the sheath extension assembly.The major bend in the guide wire body measured at 321 mm from the proximal tip.The broken core wire measured 455 mm in length, which is within the specification of guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter (od) of the guide wire measured 0.851 mm, which is within the specification of guide wire product drawing.The catheter body from the juncture hub to the distal tip measured 98 mm, which is within the specification of sheath extension assembly product drawing.The od of the catheter body measured 4.70 mm, which is within the specification of sheath extrusion product drawing.The inner diameter of the catheter body at the distal tip measured 0.118" or, 3.00 mm, which is within the specification of sheath extension assembly product drawing.A manual tug test confirmed that the proximal weld was intact.R & d was contacted as a part of this complaint investigation.They stated that the dilator is intended to be inserted into the catheter prior to the guide wire advancing through the catheter.This suggests a failure to follow the psi insertion practices.The guide wire is not intended to directly pass through the sheath valves.A device history record review was performed, and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit warns the user, "thread tapered tip of dilator/access device assembly over guidewire.Sufficient guidewire length must remain exposed at hub end of device to maintain a firm grip on guidewire.Grasping near skin, advance assembly with slight twisting motion to a depth sufficient to enter vessel.Dilator may be partially withdrawn to facilitate advancement of access device through tortuous vessel.Advance access device assembly off dilator into vessel, again grasping near skin and using slight twisting motion.Hold access device assembly in place and withdraw guidewire and dilator sufficiently to allow venous blood flow to be aspirated into distal side port.Precaution: maintain firm grip on guidewire at all times.Holding access device assembly in place, remove guidewire and dilator as a unit." the report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and catheter met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.In addition, the guide wire was returned advanced through the sheath extension assembly without the dilator.R & d stated that the dilator is intended to be inserted into the catheter prior to the guide wire advancing through which suggests a failure to follow the psi insertion practices.Based on these circumstances, use error caused or contributed to the reported event.An in-service has been initiated to instruct the customer on proper use of the device components.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19975733
• Report Number: 9680794-2024-00778
• Device Sequence Number: 20968300
• Product Code: FOZ
• UDI-Device Identifier: 30801902121920
• UDI-Public: (01)30801902121920(11)240618(17)260731(10)33F24C0024(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: AK-11142-SPCS
• Device Lot Number: 33F24C0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown