MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8IN; WIRE GUIDE CATHETER

Catalog Number	RA-04122
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on (b)(6) 2024, the doctor found the swg kinked during use on the patient.It was difficult to advance.They changed a new one to resolve the issue." there was no medical intervention required.The patient's current condition is reported as "fine.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one arterial catheterization device for analysis.No definite signs of use were observed.Visual and microscopic examination revealed two kinks towards the distal end of the guide wire.Microscopic examination confirmed the damage.The kink created resistance when being inserted through the cannula.The distal weld was present and appeared full and spherical.No other defects or anomalies were observed with any other portion of the catheterization device.Functional testing was performed based on the instructions for use (ifu).The ifu provided with this kit states, "stabilize position of introducer needle and carefully advance guidewire into vessel using guidewire handle".The returned guide wire was advanced into the needle cannula.Slight resistance was initially encountered at the proximal opening due to the kinking.Once inserted, the guide wire passed completely through the cannula with little to no resistance.The test was repeated with a lab inventory guide wire.The guide wire advanced with no resistance at any portion of the cannula.Manufacturing was contacted as part of this complaint.They confirmed that this is a verified teleflex issue via a previously opened capa.The manufacturing dates for the lot#s in question occurred prior to the capa implementation (07-oct-2024).A device history record review was performed, and a relevant finding was identified.Non-conformances were initiated to address the issue of "arterial-swg/needle resistance, kinked" and "arterial-swg kinked in package/prior to use" (respectively).Further analysis confirmed that the kinking is consistent with the kinking involved with this complaint; however, no other defects or anomalies were observed to verify it is the same manufacturing defect.The reported event was confirmed through complaint investigation of the returned sample.Visual analysis revealed kinking on the guide wire.The nature of the kinking prior to use indicates that resistance was met during initial deployment of the guide wire.A capa was previously implemented to address this issue.The capa investigation determined that the root cause is manufacturing related.The relevant lots within the reported kit were manufactured (august 2022) prior to the implementation of the corrective action (october 2024).Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2024, the doctor found the swg kinked during use on the patient.It was difficult to advance.They changed a new one to resolve the issue." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8IN
• 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: 20754951
• Report Number: 9680794-2024-01191
• Device Sequence Number: 21148339
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)220818(17)270731(10)14F22H0092(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K810675
• 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): 10/25/2024

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: RA-04122
• Device Lot Number: 14F22H0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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.
• Patient Sex: Unknown