MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL

Model Number IPN036964

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

Complaint found in maude database reports: "placement of hemodialysis line was performed.Insertion and dilation was smooth without issues.When removing catheter, there was no resistance until it was noted to be uncoiling.Removal of guidewire was then stopped.Attending came to bedside and hemodialysis catheter had to be completely removed.Due to patient having low platelets, there was large amounts of blood draining from site.A hematoma formed.Fem stop had to be applied.Lot# 13f21e0294.When advancing the catheter, the wire suddenly became unable to exchange easily.Upon attempting to remove the wire from the catheter, the metal pulled apart.The placement of the catheter was checked multiple times using the ultrasound, the catheter was found to be entering into the vein.At this point, we clamped the wire inside the catheter and removed both the wire and the device from the left femoral vein.Pressure was held on the site of the venous dilation for 45 minutes and platelets were given.We transitioned handheld pressure to a fem stop device on the left groin.The fem stop was removed per protocol after a few hours with no further bleeding.Also, the attending physician documented when she co-signed the procedure note: concern for faulty guidewire in dialysis catheter identified after catheter inserted in the left groin.".

Manufacturer Narrative

(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).

Manufacturer Narrative

(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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

Complaint found in maude database reports: "placement of hemodialysis line was performed.Insertion and dilation was smooth without issues.When removing catheter, there was no resistance until it was noted to be uncoiling.Removal of guidewire was then stopped.Attending came to bedside and hemodialysis catheter had to be completely removed.Due to patient having low platelets, there was large amounts of blood draining from site.A hematoma formed.Fem stop had to be applied.Lot# 13f21e0294.When advancing the catheter, the wire suddenly became unable to exchange easily.Upon attempting to remove the wire from the catheter, the metal pulled apart.The placement of the catheter was checked multiple times using the ultrasound, the catheter was found to be entering into the vein.At this point, we clamped the wire inside the catheter and removed both the wire and the device from the left femoral vein.Pressure was held on the site of the venous dilation for 45 minutes and platelets were given.We transitioned handheld pressure to a fem stop device on the left groin.The fem stop was removed per protocol after a few hours with no further bleeding.Also, the attending physician documented when she co-signed the pr ocedure note: concern for faulty guidewire in dialysis catheter identified after catheter inserted in the left groin.".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14057753
• MDR Text Key: 289493263
• Report Number: 9680794-2022-00221
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 70801902123304
• UDI-Public: 70801902123304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2023
• Device Model Number: IPN036964
• Device Catalogue Number: AU-22122-F
• Device Lot Number: 13F21E0294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2021
• 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
• Patient Outcome(s): Required Intervention