MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM; CATHETER PERCUTENEOUS

Model Number	IPN038325
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: incident happened during the insertion of a dialysis catheter.The incident happened at the time of removing the guide.The guide got stuck in the dilator and "fell apart".So the doctor decided to remove the device.No patient harm reported.It was reported the device was removed and another device inserted, "so it was painful for the patient".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: incident happened during the insertion of a dialysis catheter.The incident happened at the time of removing the guide.The guide got stuck in the dilator and "fell apart".So the doctor decided to remove the device.No patient harm reported.It was reported the device was removed and another device inserted, "so it was painful for the patient".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire and catheter for evaluation.The dilator was not returned.The guide wire was unraveled and both returned components showed evidence of use.Visual examination revealed the guide wire is unraveled from the distal weld and has multiple kinks in the guide wire body.The distal end of the core wire, including the distal j bend, is broken and protruding out of the coil wire.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.The exposed distal core wire tip is rounded and discolored at the point of separation.Both welds appeared full and spherical.Visual inspection of the catheter did not reveal any obvious defects or anomalies.Visual inspection of the dilator could not be performed as the dilator was not returned.The major kinks in the guide wire body were measured at 192mm and 320mm from the proximal tip.The broken core wire measured 680 mm in length which is within the specification of 678 - 688 mm per guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.846 mm which is within the specification of 0.838 - 0.877 mm per guide wire product drawing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.A manual tug test confirmed that the distal weld was intact.A device history record review was performed on the guide wire and dilator and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso (b)(4) standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire and dilator resistance could not be determined based upon the information provided and without the dilator being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 25 CM
• Common Device Name: CATHETER PERCUTENEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12800799
• Report Number: 3006425876-2021-01043
• Device Sequence Number: 17536819
• Product Code: DQY
• UDI-Device Identifier: 10801902139259
• UDI-Public: 10801902139259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• 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): 10/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2023
• Device Model Number: IPN038325
• Device Catalogue Number: CS-26122-F
• Device Lot Number: 71F21E0490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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