MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN030108

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The customer reports that the device frayed during extraction.All of the device was removed , and a new device was inserted without incident.

Manufacturer Narrative

Qn#(b)(4).Corrected data: brand name corrected to arrow cvc set: 4-lumen 8.5fr x 16cm.Catalog# corrected to cv-22854.The customer returned one spring wire guide (swg), catheter and lidstock.Visual examination of the unraveled portion of the swg revealed the wire was all tangled.The non-unraveled portion contained three kinks.The wire guide had become unraveled from the distal weld breaking from the core wire.The exposed distal core wire tip is tapered and discolored at the point of separation.The proximal weld is intact but also starting to unravel.The kinks in the guide wire measured 162mm, 318mm and 365mm from the proximal end.The length of the core wire measured 599mm which is within specifications of 596-604mm per swg product drawing.The outer diameter of the returned swg measured 0.794mm which is within specifications 0.788-0.826mm per swg product drawing.The undamaged portion of the swg was passed through the returned catheter.The swg passed through with minimal resistance.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guide wire unraveled was confirmed through examination of the returned sample.The distal weld of the guide wire had separated from the core wire.The guide wire met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the device frayed during extraction.All of the device was removed , and a new device was inserted without incident.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9757829
• MDR Text Key: 181234976
• Report Number: 3006425876-2020-00179
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: IPN030108
• Device Catalogue Number: CV-22854
• Device Lot Number: 71F19D2804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR