MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number IPN001348

Device Problems Deformation Due to Compressive Stress (2889); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The physician placed a 19cm vector flow catheter (cs-15192-vfe) to a patient on (b)(6) 2020 (vein puncture is done under echo and placement verification by x-ray).The verification image shows a "plicature/kink" of the catheter.During the dialysis, the department reports that the catheter does not work (no flow).The physician replaced the catheter on (b)(6) 2020 with a new vector flow 19cm (same technique).The second catheter also showed a kink on the x-ray.Once again, the dialysis department reports that the catheter is not working (still no flow).They decided to replace the catheter one last time with a different product and dialysis could be performed.No patient injury or complication reported.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Corrected data: section b.2.-'required intervention' checked.The customer provided one x-ray and three photos of the sample for inspection.Visual inspection of the photos confirmed that the catheter had kinked while in the patient.The customer also returned one catheter body for evaluation.Visual examination did not reveal any defects or anomalies.No obvious kinks were detected in the catheter body.The total length of the returned catheter body measured to be 341 mm which indicates at least 33 mm were intentionally trimmed and not returned per product drawing.The outer diameter of the returned catheter body measured to be 0.202" which is less than the maximum specification of 0.204" per product drawing.According to amrq-000075 rev 15, "the catheter body extrusion shall have a corrected kink radius of = 2.5 cm when tested at ambient indoor conditions." this means that the catheter should not kink unless its bend radius is less than or equal to 2.5 cm.The returned catheter was bent to a radius of 2.5 cm at various locations along the catheter body.No kinks were formed at any point.A lab inventory guide wire was able to pass through both catheter body lumens with minimal resistance.Product engineering was consulted in r egards to the customer supplied x-ray photo.They noted that it appears that the curvature on the x-ray is tighter than what the catheter is required to or intended to achieve; however, it is not clear from the photos if the kink is occurring inside the vessel, where the catheter exits the patient, or in the tunnel tract.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not create a sharp bend in catheter tunnel; kinking and reduced flow will result.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 instructs the user, "perform a small blunt dissection at venotomy toward exit site (this will minimize catheter kinking at venous insertion site).".The customer report of a kinked catheter was confirmed by evaluation of the customer supplied photos.However, no kinks were observed on the returned catheter body and the sample passed all relevant visual, dimensional, and functional testing.A device history record review was performed with no relevant findings.Based on the circumstances, the customer photos and evaluation of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The physician placed a 19cm vector flow catheter (cs-15192-vfe) to a patient on (b)(6) 2020 (vein puncture is done under echo and placement verification by x-ray).The verification image shows a "plicature/kink" of the catheter.During the dialysis, the department reports that the catheter does not work (no flow).The physician replaced the catheter on (b)(6) 2020 with a new vector flow 19cm (same technique).The second catheter also showed a kink on the x-ray.Once again, the dialysis department reports that the catheter is not working (still no flow).They decided to replace the catheter one last time with a different product and dialysis could be performed.No patient injury or complication reported.The patient's condition is reported as fine.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• Type of Device: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10817684
• MDR Text Key: 215575969
• Report Number: 9680794-2020-00448
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K141051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: IPN001348
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 13F19G0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention