MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Model Number IPN030887

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported that: "the doctor had problems removing the guide.Finally took it out and it came out frayed." additional information: it was during a central track interchange.It was difficult to advance and it was necessary to remove the guide wire together with the catheter.There was no reported patient harm.They were reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The report that the guide wire unraveled was confirmed through examination of the returned sample.The customer returned an opened c v-15703-e kit with various components including a guide wire assembly, an arrow raulerson syringe (ars) and an introducer needle for evaluation.The guide wire was partially advanced within the advancer assembly and was unraveled.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire was unraveled from the proximal weld and is bent in three locations along the body.The distal j-bend was slightly misshapen but intact.The returned catheter and insertion components (ars and needle) showed evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The core wire tip was tapered at the point of separation.Both welds were present and appeared full and spherical.The major bends in the guide wire body were measured at 185mm, 95mm, and 23mm from the distal tip and the broken core wire measured 600mm in length, via calibrated ruler which is within the specification of 596mm-604mm 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 0.793mm via calibrated micrometer which is within the od specification of 0.788mm-0.826mm per guide wire product drawing.The functional test was performed per the ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through the returned ars and 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components (distal end first) with slight resistance at the bent locations.A manual tug test confirmed that the distal weld was intact.Additionally, 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.A device history record review was performed, and no relevant findings were identified.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.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

It was reported that: "the doctor had problems removing the guide.Finally took it out and it came out frayed." additional information: it was during a central track interchange.It was difficult to advance and it was necessary to remove the guide wire together with the catheter.There was no reported patient harm.They were reported as fine.

• Brand Name: CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17115559
• MDR Text Key: 317052955
• Report Number: 9680794-2023-00400
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

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: Health Professional
• Device Model Number: IPN030887
• Device Catalogue Number: CV-15703-E
• Device Lot Number: 71F22F22H221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/03/2023
• 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
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Sex: Female