MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI; CATHETER, HEMODIALYSIS, NON-I

Model Number	IPN035502
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#( b)(4).
Event or Problem Description
The complaint is reported as: guidewire inserted smoothly and after 10cm it would not advance further so they attempted to remove the guidewire but it got stuck in the introducer.The guidewire was kinked and broken.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one spring wire guide (swg) inserted through a needle for evaluation.Signs of use in the form of biological material were present on the swg body and in the needle hub.Visual inspection of the swg revealed two kinks in the swg body near the j-bend.Microscopic examination confirmed both welds were fully formed and spherical.The kinks in the guide wire body measured 582 mm and 588 mm from the proximal weld.The total length of the swg measured 604 mm which is within specifications of 596-604 mm per swg graphic.The outer diameter of the swg measured 0.848 mm which is within specifications of 0.838-0.877 mm per swg graphic.The outer diameter of the needle measured 0.05005" which is within specifications of 0.0495-0.0505" per needle cannula graphic.The inner diameter of the needle measured 0.041" which is within specifications of 0.0410-0.0430" per needle cannula graphic.The swg was removed from the needle along with a large amount of biological material.The swg was reinserted into the returned needle per ifu which states, "advance spring-wire guide into the syringe approximately 10 cm until it passes through the syringe valves.When using an arrow raulerson syringe, advance guide wire until triple band mark reaches rear of syringe plunger.Advancement of "j" tip may require a gentle rotating motion.Hold spring-wire guide in place and remove introducer needle and arrow raulerson syringe." the swg passed through the needle with minimal resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire contained two kinks near the j-bend.The guide wire met all relevant dimensional requirements and a device history record review was performed with no relevant findings.Based on the customer report and the sample received unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: guidewire inserted smoothly and after 10cm it would not advance further so they attempted to remove the guidewire but it got stuck in the introducer.The guidewire was kinked and broken.It was reported there was no harm to the patient.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI
• Common Device Name: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12061586
• Report Number: 1036844-2021-00128
• Device Sequence Number: 3800787
• Product Code: MPB
• UDI-Device Identifier: 00801902068002
• UDI-Public: 00801902068002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: IPN035502
• Device Catalogue Number: CDC-25142-X1A
• Device Lot Number: 23F20J0234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1