MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH KIT: 20 GA X 1-1/2" (3.81 CM); WIRE, GUIDE, CATHETER

Model Number	IPN921746
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the wire was unable to be removed from catheter.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one arterial catheter and guide wire.The guide wire was inserted through the catheter and was stuck.It was noted that the returned catheter does not appear to be an arrow product.Signs of use in the form of biological material was observed.Visual analysis revealed that the guide wire was stuck inside the catheter body and was kinked.This resulted in the catheter body to also be severely kinked.An attempt to remove the guide wire from the assembly was performed; however, this resulted in the guide wire to become unraveled and separated.Upon separating , the guide wire was able to be removed out of the catheter body.It was immediately observed that the guide wire contained a j-bend, which does not match the guide wire normally packaged within this finished good.Additionally, the returned catheter also does not appear to match the catheter provided within the kit.Therefore, it is being assumed that the customer returned the wrong component, or the wrong finished good (material#/lot#) was reported.The guide wire body total length measured 45.7cm which is not within the specification limits of 44.5cm-45.5cm per the guide wire graphic.The guide wire outer diameter measured.02435" which is not within the specification limits of.0175"-.0180" per the guide wire graphic.The catheter body inner diameter measured.025" which is not within the specification limits of.031"-.033" per the catheter extrusion graphic.Functional analysis could not be accurately performed as the returned sample does not match the components normally packaged within the reported kit.A device history record review was performed on the reported kit, and no relevant findings were identified.The ifu provided with the kit informs the user, "use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter together as a unit.Use of excessive force may damage catheter or spring-wire guide".The report of a kinked guide wire was confirmed through complaint investigation of the returned components.Visual analysis revealed that the guide wire was stuck inside the catheter and was kinked.It was also observed that the returned guide wire and catheter do not match the components packaged within the reported finished good.Therefore, dimensional and functional inspection could not be accurately performed.A device history record review was performed based on the reported material#/lot#, and no relevant findings were identified.Based on the discrepancy between the returned components and reported kit, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the wire was unable to be removed from catheter.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1-1/2" (3.81 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12830490
• Report Number: 9680794-2021-00612
• Device Sequence Number: 11143248
• Product Code: DQX
• UDI-Device Identifier: 10801902200447
• UDI-Public: 10801902200447
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: 02/28/2023
• Device Model Number: IPN921746
• Device Catalogue Number: ASK-04120-HF3
• Device Lot Number: 13F21F0898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2021
• 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
• Patient Sex: Unknown