MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER HEMODIALYTSIS NON IMP

Model Number IPN030114

Device Problem Unraveled Material (1664)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/22/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported the physician was placing the catheter in the patient's left jugular vein and the guidewire unravelled making it difficult to remove.The guidewire was successfully removed, but with a lot of "teasing" it out to stop it unravelling further.There was no patient harm.Hemofiltration started as planned and no additional medical treatment was required.It was reported there was significant blood loss through the catheter, about 200ml, because it wasn't possible to remove the wire easily or quickly.

Event Description

It was reported the physician was placing the catheter in the patient's left jugular vein and the guidewire unravelled making it difficult to remove.The guidewire was successfully removed, but with a lot of "teasing" it out to stop it unravelling further.There was no patient harm.Hemofiltration started as planned and no additional medical treatment was required.It was reported there was significant blood loss through the catheter, about 200ml, because it wasn't possible to remove the wire easily or quickly.

Manufacturer Narrative

Qn#(b)(4).The customer returned one guide wire for evaluation.The catheter was not returned.Visual examination revealed the guide wire was unraveled from the proximal weld and had multiple bends in the guide wire body.The proximal end of the safety ribbon wire and the core wire were broken and protruding out of the coil wire.The distal j-bend is misshapen but intact.Microscopic examination of the guide wire confirmed the safety ribbon wire and core wire were broken adjacent to the proximal weld and that the weld was present at the end of the coil wire.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The broken safety ribbon wire measured 700 mm in length which is within the specification of 694-706 mm per guide wire product drawing; therefore no pieces of the safety ribbon wire appear to be missing.The outside diameter of the guide wire measured 0.948 mm which is within the outer diameter specification of 0.94-0.965 mm per guide wire product drawing.The outer diameter of the core wire measured 0.01795" which is within specifications of 0.013-0.023" per guide wire product drawing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.A manual tug test confirmed that the distal weld was intact.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the proximal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12484575
• MDR Text Key: 271899061
• Report Number: 3006425876-2021-00876
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100191
• UDI-Public: 00801902100191
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• 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: 08/31/2021

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 Expiration Date: 10/06/2022
• Device Model Number: IPN030114
• Device Catalogue Number: CS-22142-F
• Device Lot Number: 71F20K2166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/16/2021
• Supplement Dates Manufacturer Received: 10/19/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1