MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2L 12 FR X 25 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number ASK-46122-VG

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: i just tried putting a 20cm arrow hd line in the femoral position in a pt with above average adiposity.The line kinked up with the wire on advancement and i had to abort and re-try with another guide wire.There was no reported patient harm.They were reported as fine post the procedure.

Manufacturer Narrative

Qn # (b)(4).The customer report of a kinked guide wire was confirmed by visual inspection of the customer supplied photos; 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 Description

It was reported that: i just tried putting a 20cm arrow hd line in the femoral position in a pt with above average adiposity.The line kinked up with the wire on advancement and i had to abort and re-try with another guide wire.There was no reported patient harm.They were reported as fine post the procedure.Associated complaints 9680794-2023-00996, 9680794-2023-00998 and 9680794-2023-00953.

• Brand Name: ARROW HEMODIALYSIS KIT: 2L 12 FR X 25 CM
• Type of Device: CATHETER HEMODIALYSIS NON IMPL
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18275657
• MDR Text Key: 330787404
• Report Number: 9680794-2023-00953
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: ASK-46122-VG
• Device Lot Number: 33F23C0127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED