MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number IPN055166

Device Problems Entrapment of Device (1212); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).Associated mdr#s: 3006425876-2023-00438 (first puncture).

Event Description

The complaint is reported as: "unproblematic puncture of the right internal jugular vein under sonographic control, blood aspirable, wire advancement, resistance at the needle tip or just behind it.Resistance at needle tip or just behind, sonographically needle tip under vein, careful retraction of wire, resistance, stop, needle and wire removed, now goes easily through needle retraction, wire tip is noted as slightly deformed but is assessed as irrelevant altogether, new puncture/wire advance/dilator/catheter advance over wire, all without problems, when attempting to retract wire over catheter, wire stretches with springy resistance, wire and catheter are sonographically in vessel.Sonographically in the vessel, aspiration of blood through the medial lumen, advancement of a new wire into the lumen to gain access to the vessel, attempt to withdraw the catheter with the defective wire inside attempt to withdraw the catheter with the defective wire inside but again springy resistance, removal of the catheter with the new wire in place, the winding of the first wire remains in the child, several careful attempts to retract with and rotation of the wire are unsuccessful, surgical dissection finally to the vein wall, further resistance, careful insertion of the defective wire or winding into a cut central venous catheter a cut cvc (approx.13cm long), advancement approx.2 cm into the vein, wire not to be removed yet, careful advancement of the cvc over the wire under fluoroscopy to about the level of the right atrium, now the cvc can be removed together with the inner wire, fortunately completely, then problem-free insertion of the v.Jug.Int.Left.At no time was excessive force or even violence used, the inner wire shows no kinks or deformations." it was reported the patient had "surgical dissection ultimately up to the vein included a muscle dissection (probably omohyoideus muscle)".Surgery duration was over 2 hours and patient required multiple fluoroscopies and postoperative x-rays.The guidewire was completely removed.It was reported "apart from a surgical stitch on the neck, the patient is doing well".Additional information received (b)(6) 2023 reports: the patient had 2 punctures of the internal jugular vein on the right side with the same device.After the second puncture, the first wire remained in the first catheter and could not be removed.A second wire was inserted through the medial line lumen of the first catheter to gain vascular access and try to remove the first wire and catheter together, but this was not successful.It was reported the wire remaining in the patient was removed by "placing a cut catheter as a splint over the thin, accordion-like, lengthening wire sheath and carefully pushing it into the heart (of course, this was still the remainder of the first wire)." a third puncture was then done on the left jugular vein and was successful.

Manufacturer Narrative

(b)(4).Associated mdr#s: 3006425876-2023-00438 (first puncture).The customer returned a guide wire and a 3-lumen cvc for evaluation.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire is unraveled and separated from the distal end and is kinked/distorted in several locations along the body.The coil wire was observed to be broken and the separated distal portion (including the distal weld) was not returned for analysis.The core wire distal j-bend was deformed and exposed out of the coil wire.Microscopic examination of the guide wire confirmed the core and coils wires were broken.The proximal weld was present and appeared spherical; however, the coils directly adjacent to the proximal weld were deformed.The distal core wire separation point was tapered and flat which is consistent with a break directly adjacent to the distal weld.Examination of the catheter did not reveal any defects or anomalies.Visual examination of the distal weld could not be performed as the separated portion of the guide wire was not returned.The kinks in the guide wire measured 213mm from the proximal tip and 14mm from the distal tip.The overall length of the guide wire measured 455mm which is within the specification of 449.2-458.8 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.432mm which is within the specification of 0.432-0.457 mm per guide wire product drawing.The catheter body length from the juncture hub to the distal tip measured 5 1/2", which is within the specification limits of 5 1/4"-5 3/4" per the catheter product drawing.The catheter body outer diameter measured 0.0700", which is within the specification limits of 0.069"-0.074" per the catheter extrusion product drawing.The functional end of the returned guide wire was inserted through the distal tip of the catheter.The guide wire was able to pass with little to no issues.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire".A manual tug test confirmed that the proximal weld was secure and intact.The distal weld could not be evaluated as the separated portion of the guide wire was not returned.A device history record review was performed, and a potentially relevant finding was identified.It was determined that the finding was not relevant.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.The ifu warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.".

Event Description

The complaint is reported as: "unproblematic puncture of the right internal jugular vein under sonographic control, blood aspirable, wire advancement, resistance at the needle tip or just behind it.Resistance at needle tip or just behind, sonographically needle tip under vein, careful retraction of wire, resistance, stop, needle and wire removed, now goes easily through needle retraction, wire tip is noted as slightly deformed but is assessed as irrelevant altogether, new puncture/wire advance/dilator/catheter advance over wire, all without problems, when attempting to retract wire over catheter, wire stretches with springy resistance, wire and catheter are sonographically in vessel.Sonographically in the vessel, aspiration of blood through the medial lumen, advancement of a new wire into the lumen to gain access to the vessel, attempt to withdraw the catheter with the defective wire inside attempt to withdraw the catheter with the defective wire inside but again springy resistance, removal of the catheter with the new wire in place, the winding of the first wire remains in the child, several careful attempts to retract with and rotation of the wire are unsuccessful, surgical dissection finally to the vein wall, further resistance, careful insertion of the defective wire or winding into a cut central venous catheter a cut cvc (approx.13cm long), advancement approx.2 cm into the vein, wire not to be removed yet, careful advancement of the cvc over the wire under fluoroscopy to about the level of the right atrium, now the cvc can be removed together with the inner wire, fortunately completely, then problem-free insertion of the v.Jug.Int.Left.At no time was excessive force or even violence used, the inner wire shows no kinks or deformations." it was reported the patient had "surgical dissection ultimately up to the vein included a muscle dissection (probably omohyoideus muscle)".Surgery duration was over 2 hours and patient required multiple fluoroscopies and postoperative x-rays.The guidewire was completely removed.It was reported "apart from a surgical stitch on the neck, the patient is doing well".Additional information received 21apr2023 reports: the patient had 2 punctures of the internal jugular vein on the right side with the same device.After the second puncture, the first wire remained in the first catheter and could not be removed.A second wire was inserted through the medial line lumen of the first catheter to gain vascular access and try to remove the first wire and catheter together, but this was not successful.It was reported the wire remaining in the patient was removed by "placing a cut catheter as a splint over the thin, accordion-like, lengthening wire sheath and carefully pushing it into the heart (of course, this was still the remainder of the first wire)." a third puncture was then done on the left jugular vein and was successful.Associated mdr#s: 3006425876-2023-00438 (first puncture).

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16861769
• MDR Text Key: 314481814
• Report Number: 3006425876-2023-00426
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902153743
• UDI-Public: 10801902153743
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

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: IPN055166
• Device Catalogue Number: CS-16553-E
• Device Lot Number: 71F20G1292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 05/26/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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: ANESTHESIA.; ANESTHESIA.
• Patient Outcome(s): Required Intervention
• Patient Age: 14 MO
• Patient Sex: Female