MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1 3/4 IN; WIRE, GUIDE, CATHETER

Catalog Number	ASK-04020-ATH
Medical Device Problem Codes	Material Disintegration (1177); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "could not advance catheter.It did not move, felt stuck to the whole device.Pulled everything out.Needle was disengaged and sheared.She successfully replaced with a quickflash." no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The actual sample was not returned; however, the customer provided two photos for analysis.The complaint of an unraveled guide wire was not able to be confirmed by the photo.The guide wire was not pictured in either of the photos.The images did reveal the needle cannula separated from the needle hub.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, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: if resistance is encountered during guidewire advancement do not force feed, withdraw entire unit and attempt new puncture." the customer report of an unraveled guide wire was not confirmed by visual inspection of the customer supplied photos.The guidewire was not pictured in either of the provided photos.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "could not advance catheter.It did not move, felt stuck to the whole device.Pulled everything out.Needle was disengaged and sheared.She successfully replaced with a quickflash." no patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW RA CATH KIT: 20 GA X 1 3/4 IN
• Common Device Name: WIRE, GUIDE, 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18968583
• Report Number: 9680794-2024-00268
• Device Sequence Number: 6154853
• Product Code: DQX
• UDI-Device Identifier: 10801902164244
• UDI-Public: 10801902164244
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: ASK-04020-ATH
• Device Lot Number: 33F23K0784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2023
• 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