MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB; CATHETER HEMODIALYSIS NON IMPL

Model Number IPN036412

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

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

Event Date 05/07/2023

Event Type  malfunction  

Event Description

It was reported that: "during placement of dialysis catheter wire fractured and was retained in catheter.Wire discovered on removal of catheter due to inability to flow on crrt.However did flush and draw blood on insertion.Approximately removed within 30 mins of insertion.Placement was in left femoral routine insertion, smooth wire, increased resistance dilating.Some resistance when removing wire.Patient is fine as far as that part is concerned, approx 10cm of wire was found within catheter, did not appear to have unraveled, looks like clean shear.No retained wire." the issue was identified during use on patient, there was no reported patient harm or consequence.Patients condition is reported as fine.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "during placement of dialysis catheter wire fractured and was retained in catheter.Wire discovered on removal of catheter due to inability to flow on crrt.However did flush and draw blood on insertion.Approximately removed within 30 mins of insertion.Placement was in left femoral routine insertion, smooth wire, increased resistance dilating.Some resistance when removing wire.Patient is fine as far as that part is concerned, approx 10cm of wire was found within catheter, did not appear to have unraveled, looks like clean shear.No retained wire." the issue was identified during use on patient, there was no reported patient harm or consequence.Patients condition is reported as fine.

Manufacturer Narrative

(b)(4).The report that the guide wire separated was confirmed through examination of the returned sample.The customer returned one, 2-lumen catheter and a portion of a defective guide wire for analysis.Signs-of-use in the form of biological material were observed on the catheter.Visual examination revealed the guide wire was unraveled from the proximal weld and was separated; however, only a section of the proximal end of coil wire was returned.Microscopic examination of the guide wire confirmed that the core wire had broken adjacent to the proximal weld and that the weld was present at the end of the coil wire.Visual analysis could not be performed on the entire guide wire as it was not returned for analysis.No defects or anomalies were observed with the returned catheter.The catheter body length from the juncture hub to the distal tip measured 148mm via calibrated ruler, which is within the specification limits of 147mm-167mm per the catheter product drawing.The catheter body outer diameter measured 4.707mm via calibrated micrometer, which is within the specification limits of 4.620mm-4.720mm per the catheter extrusion product drawing.Dimensional analysis could not be accurately performed on the portion of the guide wire due to severity of damage and the fact that only a small section of the guide wire was returned.A lab inventory guide wire with a diameter of 0.035" was inserted through the returned catheter as per ifu s tatement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." little to no resistance was encountered as the guide wire passed completely through the catheter.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.Additional testing could not be performed as part of this complaint investigation due to the severity of the damage to the guide wire.The ifu provided with the kit informs 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".A device history record review was performed, and no relevant manufacturing issues were identified.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.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.Regardless of these circumstances, the root cause cannot be determined as the entire guide wire was not returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB
• Type of Device: CATHETER HEMODIALYSIS NON IMPL
• 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 27560
• MDR Report Key: 17071704
• MDR Text Key: 316602388
• Report Number: 9680794-2023-00377
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 50801902123515
• UDI-Public: 50801902123515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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?: No
• Device Model Number: IPN036412
• Device Catalogue Number: CDC-22142-1A
• Device Lot Number: 33F23B0977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2023
• 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.