MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-42703-SL

Device Problem Unraveled Material (1664)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The customer returned one guide wire for analysis.The introducer needle was not returned.No definite signs-of-use were observed.The major kinks in the guide wire measured 128mm, 255mm, and 275mm ruler: (b)(4) from the distal weld.A manual tug test confirmed the distal weld was secure and intact.The total length of the returned core wire measured to be 602mm ruler: (b)(4) which is within specification.The undamaged portion of the swg passed through the lab inventory introducer needle/ars subassembly with minimal resistance.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.The guide wire met all relevant dimensional and functional requirements, 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 user error likely contributed to this event; however, the probable cause of guide wire/needle resistance could not be determined based upon the information provided and without the needle being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported the needle was inside the vessel.The user inserted the wire and felt resistance.The wire frayed.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12565156
• MDR Text Key: 274434741
• Report Number: 9680794-2021-00486
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 09/10/2021

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: No Information
• Device Catalogue Number: ASK-42703-SL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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