MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6IN (16 CM); CATHETER PERCUTANEOUS

Catalog Number	ES-04706
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, before insertion, the doctor found the swg unraveled prior to the patient.They changed a new one.No harm for the patient.".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo revealed unraveling and separation of the coil wire at the distal end.The customer also returned multiple components of a cvc kit, including one guide wire assembly, for analysis.Definite signs of use were observed on the guide wire in the form of biological material.Visual inspection of the guide wire coil wire revealed it was unraveled and separated in the middle of the body and kinked in multiple locations.The distal j-bend appeared intact.The distal portion of the coil wire was separated and not returned for analysis.Microscopic examination confirmed the guide wire core wire separated directly adjacent to the distal weld.The proximal weld was still present on the coil wire and appeared full and spherical.The damage was reported to have occurred prior to use; however , it cannot be determined when the guide wire unraveled and separated as it would have been protected by the advancer assembly during transit and storage.No evident damage was observed to the guide wire assembly or product packaging.The biological material and condition of the returned sample additionally suggests customer handling of the sample.The kinks measured 520, 561, and 580mm from the proximal tip.The broken core wire length measured 598mm, which is not within the specifications of 450mm - 458mm per guide wire product drawing.The guide wire outer diameter measured 0.80mm , which is within the specifications of 0.788mm-0.826mm per guide wire product drawing.The dimensional discrepancy indicates that the customer either reported the incorrect material or returned the incorrect guide wire for analysis.Functional inspection of the guide wire could not be performed due to the damage.A manual tug test confirmed the proximal weld was fully secure and intact.A device history record review was not required as part of this complaint investigation.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 report that the spring wire guide was unraveled and separated was confirmed through visual examination of the returned sample.Definite evidence of use was observed on the guide wire.The guide wire core wire separated directly adjacent to the distal weld.The coil wire was additionally separated in the middle of the body and not returned.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.The guide wire would have been protected within its protective tubing and packaging during storage and shipping, so it cannot be confirmed when the guide wire was damaged.Dimensional analysis of the guide wire additionally revealed a discrepancy between the returned guide wire length and reported finished good.Therefore, based on these circumstances, the root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "on (b)(6) 2024, before insertion, the doctor found the swg unraveled prior to the patient.They changed a new one.No harm for the patient.".

• Brand Name: ARROW CVC SET: 14 GA X 6IN (16 CM)
• Common Device Name: 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: 20772291
• Report Number: 3006425876-2024-01180
• Device Sequence Number: 8005006
• Product Code: DQY
• UDI-Device Identifier: 00801902108418
• UDI-Public: (01)00801902108418(11)230331(17)280229(10)71F23C1907(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2024

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: Health Professional
• Device Catalogue Number: ES-04706
• Device Lot Number: 71F23C1907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown