MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 5 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number	IPN037202
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The compliant is reported as: "during line placement in the or, an arrow ped 2 lumen cvp kit used (ref ak-14502) while removing the guidewire from the patient the catheter frayed.Able to remove the entire catheter." no patient harm was reported.The patient's condition is reported as fine.
Event or Problem Description
The compliant is reported as: "during line placement in the or, an arrow ped 2 lumen cvp kit used (ref ak-14502) while removing the guidewire from the patient the catheter frayed.Able to remove the entire catheter." no patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one spring wire guide (swg) and 2-l cvc catheter for investigation.The lidstock was also returned.Signs of use in the form of biological material were present on the catheter body.Visual inspection of the swg revealed that the core wire had separated near the distal weld and the swg was unraveled.Two bends were observed in the swg body.Microscopic examination of the guide wire confirmed the core wire was broken near the distal weld.Both welds were present and appeared full and spherical.The bends in the guide wire body measured 270 mm from the proximal weld and 18 mm from the distal weld.The length of the core wire nearest to the distal weld measured 24mm.The remaining portion of the core wire measured 433 mm.The total length of the two separated portions of the swg core wire measured 457 mm which is within specifications of 449.2-458.8 mm per swg product drawing.The outer diameter of the swg measured 0.518 mm within specifications of 0.508-0.533 mm per swg product drawing.The total length of the catheter body measured 5 3/16" which is within specifications of 4 13/16" - 5 3/16" per catheter product drawing.The outer diameter of the catheter body measured 0.067" which is within specifications of 0.065"-0.069" per catheter extrusion graphic.The instructions for use (ifu) provided with this kit 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 undamaged portion of the swg was inserted through the distal luer and into the catheter body to functionally test.The undamaged portion of the swg was able to pass through the catheter with minimal resistance.A manual tug test confirmed the proximal and distal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit 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." the report that the guide wire separated was confirmed through examination of the returned sample.Microscopic examination of the guide wire confirmed the core wire was broken near the distal weld.A device history record review was performed on the catheter and guide wire provided within this kit with no relevant findings.Arrow guide wires like the one provided within the reported kit are designed and manufactured to withstand a tensile force of 2 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.Therefore, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC KIT: 2-LUMEN 5 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12199565
• Report Number: 9680794-2021-00350
• Device Sequence Number: 1481055
• Product Code: DQY
• UDI-Device Identifier: 20801902122036
• UDI-Public: 20801902122036
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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
• Operator of Device: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: IPN037202
• Device Catalogue Number: AK-14502
• Device Lot Number: 13F20M0474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1