MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AHDC AGB KIT: 2-L 14 FR X 20 CM; CATHETER, HEMODIALYSIS, TRIPLE

Catalog Number	CDC-25142-XCN1A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d11: c acidosis and hypotensive requiring vasopressor support.He required a temporary hd catheter for initiation of crrt.The patient was a large man with a significant amount of subcutaneous adipose tissue.Qn#(b)(4).
Event or Problem Description
We elected to place a temporary hd catheter in the femoral vein on the r because of access issues.We were able to easily access the vein using us guidance.We thread the wire and confirmed venous placement.A large skin incision was made to accommodate the dilators and catheter.The problem began upon dilation.We encountered more resistance than expected during dilation and upon trying to advance the catheter on the first attempt.I attempted to advance the catheter myself but was unsuccessful.At that time, i elected to pull the catheter out, change try another kit.I threaded a catheter over the wire, removed the old wire which had a very small kink and replace it with a new wire.I then re-dilated with both dilators and then tried to advance the new 20cm 14f hd catheter.I was unsuccessful.I met a significant amount of resistance, approximately 8-10cm in, and despite many maneuvers to advance, i was unsuccessful.The catheter was too soft and would start to kink under the skin.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
Continuation of d11: c acidosis and hypotensive requiring vasopressor support.He required a temporary hd catheter for initiation of crrt.The patient was a large man with a significant amount of subcutaneous adipose tissue.Qn#(b)(4).The actual device was not returned; however the customer provided two photos for analysis.The complaint of a dilator tip damage was able to be confirmed by the photos.Definite signs of use were observed.The appearance of the damage is consistent with unintentional force applied during insertion, however, a complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding , or component damage." the customer report of dilator tip damage was confirmed by visual inspection of the customer supplied photos.The dilator pictured provided by the customer had a deformed tip, however, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
We elected to place a temporary hd catheter in the femoral vein on the r because of access issues.We were able to easily access the vein using us guidance.We thread the wire and confirmed venous placement.A large skin incision was made to accommodate the dilators and catheter.The problem began upon dilation.We encountered more resistance than expected during dilation and upon trying to advance the catheter on the first attempt.I attempted to advance the catheter myself but was unsuccessful.At that time, i elected to pull the catheter out, change try another kit.I threaded a catheter over the wire, removed the old wire which had a very small kink and replace it with a new wire.I then re-dilated with both dilators and then tried to advance the new 20cm 14f hd catheter.I was unsuccessful.I met a significant amount of resistance, approximately 8-10cm in, and despite many maneuvers to advance, i was unsuccessful.The catheter was too soft and would start to kink under the skin.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: ARROW AHDC AGB KIT: 2-L 14 FR X 20 CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE
• 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: 18561999
• Report Number: 9680794-2024-00080
• Device Sequence Number: 20498281
• Product Code: NIE
• UDI-Device Identifier: 10801902213553
• UDI-Public: 10801902213553
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 12/28/2023

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: 04/13/2025
• Device Catalogue Number: CDC-25142-XCN1A
• Device Lot Number: 33F23G0115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• 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: BACKGROUND, THE PATIENT WAS IN ARF WITH A METABOLI; BACKGROUND, THE PATIENT WAS IN ARF WITH A METABOLI
• Patient Sex: Male