MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 20GAX8CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037847
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch received reports: "endurance catheter was being placed by primary rn; primary rn states that while attempting to removed the catheter from the patient's arm she felt resistance.Once the catheter was removed completely part of the guidewire was missing." additional information received reports an x-ray of the right arm showed no apparent radiopaque foreign bodies and no foreign body was visualized on ultrasound.No intervention was done as the guidewire could not be visualized in the patient.The catheter was removed and a new catheter was placed at a different insertion site.It was reported "patient is stable and was safely discharged.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Medwatch received reports: "endurance catheter was being placed by primary rn; primary rn states that while attempting to removed the catheter from the patient's arm she felt resistance.Once the catheter was removed completely part of the guidewire was missing." additional information received reports an x-ray of the right arm showed no apparent radiopaque foreign bodies and no foreign body was visualized on ultrasound.No intervention was done as the guidewire could not be visualized in the patient.The catheter was removed and a new catheter was placed at a different insertion site.It was reported "patient is stable and was safely discharged.
Additional Manufacturer Narrative
(b)(6).The customer report of a separated guide wire was confirmed through complaint investigation of the returned sample.The customer returned one endurance catheterization device for analysis.Definite signs of use were observed.Visual analysis of the guide wire revealed that the guide wire contained one major kink towards the proximal end.The distal portion of the guide wire was also observed to be separated.Microscopic examination confirmed the damage and revealed that a portion of the guide wire was not returned for analysis.A second endurance catheterization device was returned, but it was clarified by the customer that it was a functional device used to complete the procedure, and both were returned to provide comparison between the two.The guide wire kink measured 1/2" from the proximal tip.The overall length of the guide wire measured 11.5which was not within the specification limits of 12 3/64" - 12 13/64" per the guide wire product drawing.All these measurements were done via calibrated ruler.This confirms that the entire guide wire was not returned for analysis, with at least 35/64" not returned.The outer diameter (od) of the guide wire measured 0.097" via calibrated calipers which was within the specification limits of 0.097" - 0.0103" per measurement of the guide wire product drawing.The od of the needle measured 0.0282" via calibrated micrometer which was within the specification limits of 0.0280" - 0.0285" per the needle cannula product drawing.The inner diameter (id) of the needle cannula at the distal tip measured 0.0160" via calibrated pin gauge which was within the specification limits of 0.0155" - 0.0170" per the needle cannula product drawing.A manual tug test confirmed that the guide wire was secure within the slider.The ifu provided with this kit informs the user "caution: do not force guidewire if resistance is encountered during advancement.Warning: do not retract guidewire through needle while in vessel to reduce risk of guidewire damage and embolization.If it is necessary to withdraw guidewire once deployed, needle and guidewire should be removed as a unit." a device history record review was performed, and no relevant findings were identified.Based on the customer report and despite one portion of the guide wire not being returned for analysis, unintentional use error likely caused or contrib uted to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX8CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17325196
• Report Number: 9680794-2023-00505
• Device Sequence Number: 17714736
• Product Code: FOZ
• UDI-Device Identifier: 10801902132953
• UDI-Public: 10801902132953
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K151513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 12/31/2024
• Device Model Number: IPN037847
• Device Catalogue Number: EDC-00820
• Device Lot Number: 14F23A0311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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.
• Patient Age: 30 YR
• Patient Sex: Male