MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 22 GA X 4" (10 CM); CATHETER PERCUTANEOUS

Model Number IPN039978

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

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

It was reported that "during insertion of cvc on a 20-month-old baby, the doctor observed that the swg does not advance in the catheter.There is important resistance with risk to damage the swg." the guidewire was changed and cvc inserted successfully without issue.It was reported there was an increase of genereal anesthesia time.The infant was under anesthesia a total time of 1 hour and 30 minutes.It was reported "the infant was discharged from hospital.No clinical consequences related to the incident.".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(6) the report that the guide wire unraveled was confirmed through examination of the returned sample.The customer returned a guide wire a 21ga introducer needle for evaluation.There were no obvious signs-of-use observed on the returned components.Visual examination revealed the guide wire was unraveled from the distal weld and was bent in multiple locations along the body.The bill of materials showed that the guide wire included in this kit was supposed to be straight.The returned introducer needle did not show obvious defects or anomalies.The separation point of the core wire was towards the distal end of the guide wire.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was tapered and discoloured at the point of separation.Both welds were present and appeared full and spherical.The bends in the guide wire measured approximately 19mm and 31mm from the proximal tip.The broken core wire measured 35.2cm which was within the specification limits of 34.4cm-35.6cm per the guide wire product drawing; therefore, no pieces of the core wire appeared to be missing.The bends and the b roken core wire length were measured via calibrated ruler.The outer diameter (od) of the guide wire measured 0.020" which was within the specification limits of 0.020"-0.021" per the guide wire product drawing.The outer diameter (od) of the needle cannula measured 0.0321", which was within the specification limits of 0.0320"-0.0325" per the needle cannula product drawing.The outer diameter of the guidewire and needle cannula were measured via calibrated micrometer.The inner diameter (id) of the needle cannula measured 0.023" via calibrated pin gauge which was within the specification limits of 0.0225"-0.0240" per the needle cannula product drawing.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "insert desired tip of spring-wire guide through introducer needle or catheter into vein.The spring-wire guide should then be advanced in the routine fashion to the desired depth." the undamaged proximal end of the guide wire was advanced through the returned 21ga introduce.The undamaged portions of the guide wire passed through the needle cannula with little to no difficulty.A manual tug test confirmed that the proximal weld was secure and intact.The instructions-for-use (ifu) provided with the kit warns the user, "warning: although the incidence of spring wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the wire." in addition, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." a device history record review was performed, and there were no relevant findings.Arrow guide wires of this size were designed and manufactured to withstand a tensile force of 2.0 pounds force.The selected insertion site and patient anatomy might present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage might occur if a force greater than the design specification was 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 "during insertion of cvc on a 20-month-old baby, the doctor observed that the swg does not advance in the catheter.There is important resistance with risk to damage the swg." the guidewire was changed and cvc inserted successfully without issue.It was reported there was an increase of genereal anesthesia time.The infant was under anesthesia a total time of 1 hour and 30 minutes.It was reported "the infant was discharged from hospital.No clinical consequences related to the incident.".

• Brand Name: ARROW CVC SET: 22 GA X 4" (10 CM)
• 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: 17463555
• MDR Text Key: 320629526
• Report Number: 9680794-2023-00597
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902100559
• UDI-Public: 00801902100559
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

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 Expiration Date: 10/31/2023
• Device Model Number: IPN039978
• Device Catalogue Number: ES-04522
• Device Lot Number: 14F19J0158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/04/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• 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 Age: 20 MO