MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920515
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "tip of catheter is damaged" during use.No patient harm was reported.A new catheter was used.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "tip of catheter is damaged" during use.No patient harm was reported.A new catheter was used.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one acute hemodialysis catheter for analysis.Signs of use in the form of biological material were observed.Visual analysis did not reveal any defects or anomalies of any kind.The catheter contained a split arterial/venous tip as expected.The catheter body length measured 30.3cm, which is within the specification limits of 29.3cm-30.7cm per the catheter product drawing.The length from the proximal end of cuff to the distal tip (per measurement e in the catheter product drawing) measured 23cm, which is within the specification limits of 22.7cm-23.3cm.The length from the arterial tip to the venous tip (per measurement f in the catheter product drawing) limits of 2.5cm-3.5cm.The outer diameter of the catheter body measured 0.2065", which is within the specification limits of 0.201"-0.207" per the catheter extrusion product drawing.The inner diameter of the venous tip measured 0.080", which equals the nominal value of 0.080" per the catheter product drawing.A lab inventory 0.038" guide wire was inserted through the distal end of venous extrusion and passed out of the third skive hole and re-inserted through the first skive hole of the arterial extrusion.The guide wire was fully advanced through catheter body with little to no issue and exited the arterial extension line (red hub).Performed per ifu statement, "exposed end of guidewire should be inserted into the venous (longer) tip of the catheter and passed out the third inside hole and re-inserted through the first outer side hole of the catheter on the arterial tip into the arterial lumen.Guidewire should extend through the arterial lumen and out of the red hub connector".A lab inventory syringe was attached to both extension lines and flushed.No blockages were encountered.The returned catheter extension lines were connected to the leak tester.The distal end of the catheter body was clamped, and the lines were pressurized to 300kpa for 30 seconds.No leaks were observed.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "the arrow edge hemodialysis catheter is a long-term catheter with a v tip design.This catheter is first tunneled antegrade to venous insertion site, followed by vessel access and tip placement".The ifu also states, "do not use if package is da maged".The report of damage to the catheter tip was not able to be confirmed through complaint investigation.The returned catheter met all relevant visual/dimensional/functional requirements and the catheter contained a split arterial/venous tip as expected.No obvious defects were observed.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 17842320
• Report Number: 9680794-2023-00775
• Device Sequence Number: 14553340
• Product Code: MSD
• UDI-Device Identifier: 00801902096364
• UDI-Public: 00801902096364
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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: 04/30/2026
• Device Model Number: IPN920515
• Device Catalogue Number: CS-15282-I
• Device Lot Number: 33F23C0877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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: 67 YR
• Patient Sex: Unknown
• Patient Weight: 95 KG