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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CAATHETER, HEMODIALYSIS, IMPLA
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ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CAATHETER, HEMODIALYSIS, IMPLA Back to Search Results
Catalog Number CS-15272-VFE
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2023
Event Type  malfunction  
Event Description
It was reported that: "following catheter over guide wire replacement, patency of the catheter was confirmed with contrast under vision by the doctor, however, says he couldn't get blood back as he aspirated.Instead, he was pulling air but when he flush with heparin flushing was flowing easily.The doctor removed the catheter." the device was removed and another brand of catheter was inserted.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that: "following catheter over guide wire replacement, patency of the catheter was confirmed with contrast under vision by the doctor, however, says he couldn't get blood back as he aspirated.Instead, he was pulling air but when he flush with heparin flushing was flowing easily.The doctor removed the catheter." the device was removed and another brand of catheter was inserted.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn#(b)(6) 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.The ifu provided with this kit informs the user, "securely attach red connector of catheter to tunneler tip.Ensure parts are securely snapped together before pulling catheter through tunnel tract.Remove catheter clamp.Carefully pull tunneling device through the tract (laterally) until the catheter is clear of exit site.Once catheter is pulled through tunnel, check that proximal circumferential mark is close to exit site.Use exit site mark on catheter to ensure that cuff is positioned properly." based on the customer description, the customer did not perform the procedure as recommended by the ifu.The complaint description states "the catheter cuff was clean---which means he did not tunnel it.He railroaded the guidewire through an opposition catheter and then inserted arrow catheter, but never tunnelled." this likely caused or contributed to the customer report.Therefore, as stated within the description, a customer in-service will be conducted to inform the customer.Based on the available information, intentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
 
Manufacturer Narrative
(b)(4).The customer returned one chronic hemodialysis catheter assembly and lidstock for analysis.Signs of use in the form of biological material were observed.It was immediately noted that the catheter was not assembled.Therefore, it is being assumed that the customer disassembled after encountering the reported defect.After failing functional testing (see below), leaks were observed at the location where the cannulas attached to the juncture hub of the connector assembly.Microscopic examination confirmed the location of the leaks; however, no obvious damage was observed.The hemodialysis was fully assembled as intended.Amrq-000075 states, "there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per bs en iso-10555-1 annex c." both luer hubs of the catheter were connected to the leak tester and pressurized to 300kpa while the distal end of the catheter was occluded.When flushing the arterial and venous extension lines, water was observed exiting the opposite line.No leaks were noted from any other portion of the assembly.The catheter was disassembled, and the connector assembly was attached to the leak tester and pressurized to 300kpa.When pressurizing both the venous and arterial lines , water was observed leaking at the connection of the metal cannulas and the juncture hub.A manual tug test confirmed both the arterial and venous luer hubs were securely attached to their respective extension lines.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the ifu also warns, "ensure compression sleeve is securely positioned inside threaded compression cap.Avoid attempts to place compression sleeve onto hub connection assembly cannula and then apply threaded compression cap.Incomplete compression may occur causing catheter separation." the complaint of a leaking catheter was able to be confirmed based on a complaint investigation of the returned sample.Functional testing of the catheter revealed leaking at the proximal ends of the cannulas.A device history record review was performed with no relevant findings.Based on the sample returned , manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
It was reported that: "following catheter over guide wire replacement, patency of the catheter was confirmed with contrast under vision by the doctor, however, says he couldn't get blood back as he aspirated.Instead, he was pulling air but when he flush with heparin flushing was flowing easily.The doctor removed the catheter." the device was removed and another brand of catheter was inserted.The patient's condition is reported as fine.
 
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Brand Name
ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
Type of Device
CAATHETER, 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 Key17785962
MDR Text Key323895924
Report Number9680794-2023-00677
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCS-15272-VFE
Device Lot Number13F22K0254
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
Patient Age68 YR
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