MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-25123-F

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports in the nursing department, the swg (spring wire guide) was found kinked prior to patient use.

Event Description

The customer reports in the nursing department, the swg (spring wire guide) was found kinked prior to patient use.

Manufacturer Narrative

(b)(4).The customer returned multiple components from a 3-lumen 12 fr x 20 cm cvc set kit.The spring-wire guide (swg) was returned inside of the swg tubing and unraveled.Visual examination of the swg revealed the guide wire is unraveled from the distal weld.The distal end of the core wire protruding was flat.The swg body also contained a kink.Microscopic examination of the swg confirmed the inner core wire fractured off adjacent to the distal weld.The distal weld was present at the end of the unraveled coil wire and the proximal weld was still intact.Both the proximal and distal welds appeared full and spherical.Microscopic examination also revealed offset coils at the location of the kink.The kink (with offset coils) was located approximately 360 mm from the proximal weld.The broken core wire measured 685 mm in length, which is within specification; therefore, no pieces appear to be missing.The outer diameter of the guide wire measured 0.856 mm, which is also within specification.A lab inventory swg with an outer diameter of.861 mm was able to pass through the returned catheter, introducer needle, and arrow raulerson syringe (ars), without restriction.This indicates that a swg with an outer diameter of.856 mm would be able to pass through the components as well.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed and no relevant findings were identified.The instructions for use provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire.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 was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld and contained a kink and offset coils.Functional testing showed a guide wire could passed freely through other components within the kit, and 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 the information provided and the condition of the returned sample the probable cause of this issue is operational context.

Event Description

The customer reports in the nursing department, the swg (spring wire guide) was found kinked prior to patient use.

Manufacturer Narrative

(b)(4).The customer returned multiple components from a 3-lumen 12 fr x 20 cm cvc set kit.The spring-wire guide (swg) was returned inside of the swg tubing and unraveled.Visual examination of the swg revealed the guide wire is unraveled from the distal weld.The distal end of the core wire protruding was flat.The swg body also contained a kink.Microscopic examination of the swg confirmed the inner core wire fractured off adjacent to the distal weld.The distal weld was present at the end of the unraveled coil wire and the proximal weld was still intact.Both the proximal and distal welds appeared full and spherical.Microscopic examination also revealed offset coils at the location of the kink.The kink (with offset coils) was located approximately 360 mm from the proximal weld.The broken core wire measured 685 mm in length, which is within specification; therefore, no pieces appear to be missing.The outer diameter of the guide wire measured 0.856 mm, which is also within specification.A lab inventory swg with an outer diameter of.861 mm was able to pass through the returned catheter, introducer needle, and arrow raulerson syringe (ars), without restriction.This indicates that a swg with an outer diameter of.856 mm would be able to pass through the components as well.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed and no relevant findings were identified.The instructions for use provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire.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 was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld and contained a kink and offset coils.Functional testing showed a guide wire could passed freely through other components within the kit, and 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 the information provided and the condition of the returned sample the probable cause of this issue is operational context.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7553854
• MDR Text Key: 109572268
• Report Number: 3006425876-2018-00337
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: CS-25123-F
• Device Lot Number: 71F17C0995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1