MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH KIT: 20 GA X 4.45 CM; WIRE, GUIDE, CATHETER

Catalog Number	NA-04020-1A
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: after good blood return , slowly advanced guidewire and met resistance.Attempted to easily retract yet met resistance.Removed entire unit w/o any damage to wire nor catheter.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.The swg was returned to engineers severely kinked.Therefore the complaint was changed to reportable as this is a previously reported issue.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one catheterization device for analysis.Definite signs of use were observed within the guide wire protective tubing and needle hub.Visual analysis of the guide wire revealed that it was lodged within the catheter.The guide wire was removed from the catheter to further analyze both components.The guide wire was kinked in multiple locations and the catheter was kinked towards the distal tip at the same locations.Once the catheter was removed, large amounts of dried biomaterial were observed on the guide wire body.During functional testing (see functional), the guide wire encountered resistance/an occlusion when retracting through the needle cannula.Presence of adhesive could not be confirmed within the catheterization device.It was also noted that the guide wire tubing was kinked and damaged.The major guide wire kinks measured 10mm and 15mm from the distal tip.The guide wire outer diameter measured 0.452mm, which is within the specification limits of 0.432mm-0.457mm per the guide wire product drawing.The catheter inner diameter at the proximal end measured 0.032", which is within the specification limits of 0.031"-0.034" per the catheter extrusion product drawing.The catheter was almost fully deployed off the guide wire.Slight force was required due to the kinking on the catheter and the guide wire.Once removed, it was confirmed that several kinks on the guide wire lined up with the locations of the kinking on the catheter body.Performed per ifu statement, "hold catheter in place and remove guidewire and or assembly, where applicable.Pulsatile blood flow indicates positive arterial placement".An attempt to retract the guide wire back through the cannula was also performed; however, the guide wire experienced significant resistance within the cannula and could not be successfully retracted.It cannot be determined what caused the resistance between the guide wire and needle.A manual tug test confirmed that the distal weld was secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel." the ifu also states, "warning: do not use excessive force in removing catheter.If resistance is met on removal, stop and follow institutional policies and procedures for difficult to remove catheters.".The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was fully deployed and kinked.The catheter body was partially deployed and stuck over the guide wire.Kinking was noted on the catheter in several of the same locations on the guide wire.Visual and functional examination revealed a buildup of biological material on the entire catheterization device.The customer reported that resistance was encountered when advancing the guide wire.Based on the condition of the returned sample, it cannot be determined if a blockage was present during initial use of the device.Based on these circumstances, the potential root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: after good blood return , slowly advanced guidewire and met resistance.Attempted to easily retract yet met resistance.Removed entire unit w/o any damage to wire nor catheter.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.The swg was returned to engineers severely kinked.Therefore the complaint was changed to reportable as this is a previously reported issue.
Event or Problem Description
It was reported that: after good blood return , slowly advanced guidewire and met resistance.Attempted to easily retract yet met resistance.Removed entire unit w/o any damage to wire nor catheter.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.The swg was returned to engineers severely kinked.Therefore the complaint was changed to reportable as this is a previously reported issue.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only.

• Brand Name: ARROW RA CATH KIT: 20 GA X 4.45 CM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18383051
• Report Number: 9680794-2023-01014
• Device Sequence Number: 7805807
• Product Code: DQX
• UDI-Device Identifier: 10801902119916
• UDI-Public: (01)10801902119916(11)230405(17)250331(10)33F23C0314(21)
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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 Expiration Date: 03/31/2025
• Device Catalogue Number: NA-04020-1A
• Device Lot Number: 33F23C0314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/01/2024; Not provided
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/01/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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.; NOT REPORTED.
• Patient Sex: Unknown