MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number IPN031665

Device Problem Material Deformation (2976)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Cardiogenic Shock (2262)

Event Date 05/08/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the spring wire guide kinked during patient use.

Manufacturer Narrative

Qn#(b)(4).The customer was contacted via phone and confirmed that no further information is available.The customer returned one guide wire assembly and dilator for evaluation.Visual examination of the guide wire revealed numerous kin ks/bends along the body of the wire.After the wire failed the manual tug test, the distal weld was microscopically examined.The weld contained signs of necking, which indicated undue force contributed to the breakage.The core wire was separated directly adjacent to the weld.The prominent kinks in the guide wire body were located 80, 270, and 510 mm from the distal end.The outer diameter of the returned guide wire measured to be 0.796 mm which is within specifications of 0.788-0.826 mm per product drawing.The total length of the returned core wire measured to be 680 mm which is not within specifications of 596-604 mm per product drawing.This indicates that the incorrect guide wire was returned or the incorrect product code was reported.The undamaged portions of the returned guide wire were able to advance through the returned dilator with minimal resistance.A manual tug test revealed the distal weld was not secured to the core wire.The proximal weld was fully intact.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit warns the user, "do not apply undue force on guidewire to reduce risk of possible breakage.Do not apply excessive force in removing guidewire or catheter.If withdrawal cannot be easily accomplished, a visual image should be obtained and further consultation requested." the customer report of a damaged guide wire was confirmed by complaint investigation of the returned sample.The guide wire contained numerous kinks and bends along the body.The distal weld was also separated from the core wire, partially unraveling the wire.The guide wire did not meet length requirements, indicating that the incorrect sample was returned, or the incorrect product code was reported.A device history record review was performed with no relevant findings.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 (undue force) likely contributed to this event, however, the probable cause of guide wire damage could not be determined based on the discrepancy between the customer report and the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the spring wire guide kinked during patient use.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10082659
• MDR Text Key: 191821935
• Report Number: 3006425876-2020-00450
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 05/09/2020

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 Operator: Health Professional
• Device Model Number: IPN031665
• Device Catalogue Number: EU-15854-CVT
• Device Lot Number: 71F20C2719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Initial Date Manufacturer Received: 05/09/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death