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

Catalog Number CV-26702-E

Device Problem Material Separation (1562)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "patient who requires advancement of the central catheter, when advancing the guide, it fractures even so, the specialist dilates and advances the catheter, but when withdrawing it, the guide is forced out and damages the catheter".It was reported there were two devices used with the patient.The patient's condition was reported as critical, but the damage to the catheter was unrelated to the patient's condition.It was reported the patient did not have any complications.The patient had to be punctured twice.

Event Description

The complaint is reported as: "patient who requires advancement of the central catheter, when advancing the guide, it fractures even so, the specialist dilates and advances the catheter, but when withdrawing it, the guide is forced out and damages the catheter".It was reported there were two devices used with the patient.The patient's condition was reported as critical, but the damage to the catheter was unrelated to the patient's condition.It was reported the patient did not have any complications.The patient had to be punctured twice.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen catheter and one spring wire guide (swg) for evaluation.The components showed evidence of use in the form of biological material.Visual examination revealed the guide wire is unraveled from the distal weld and is kinked/distorted in several locations along the body.The core wire distal j-bend was deformed and exposed out of the coil wire.The returned catheter show evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip is tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.The broken core wire measured 596 mm in length, which is within the specification of 596-604 mm per guide wire product drawing, therefore no pieces of the core wire appear to be missing.The outside diameter (od) of the guide wire measured 0.800 mm which is within the od specification of 0.788-0.826 mm per guide wire product drawing.The catheter body length measured 218 mm which is within the specification of 207-227 mm per catheter product drawing.A lab inventory swg was passed through the catheter per ifu which states, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." the swg was able to pass through the catheter 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 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 unraveled/separated was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and catheter 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.

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11824676
• MDR Text Key: 251432374
• Report Number: 3006425876-2021-00415
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/13/2022
• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F20L2643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR