MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-15703-M
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not available for returned; however, the customer provided one photo for analysis.The complaint of a fractured guide wire was able to be confirmed by the photo.The photo displayed a guide wire with evidence of a fractured and exposed core wire.The distal end of the coil wire was not pictured to confirm whether a complete separation occurred.Without the catheter and guide wire returned for analysis, a complete visual inspection to determine the cause of the damage could not be performed.A device history record review was performed, and a finding was identified.Further review of the finding revealed that it was not relevant to the reported event.The instructions for use (ifu) provided with this kit warns the user, "warning: do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested.The arrow catheter included in this product has been designed to freely pass over the spring-wire guide.If resistance is encountered when attempting to remove the guidewire after catheter placement, the guidewire may be kinked about the tip of the catheter within the vessel." the customer report of a fractured guide wire was confirmed by visual inspection of the customer supplied photo.The image shows a guide wire with evidence of a fractured and exposed core wire, however, full complaint verification testing to determine the cause of the damage could not be performed as no sample was returned or catheter photo provided for analysis.A device history record review was performed, and no relevant findings were identified.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.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the cvc is placed and a metal guidewire and catheter are inserted, but when the guidewire is removed it is difficult to remove and is fractured.The doctor performed the removal of the guidewire without surgical intervention.There was no reported patient harm from the incident." it was reported by the clinical staff at the hospital that: the patient died 17days later, reported cause of death was: metabolic acidosis 3 days, septic shock 12 days, post-cardiorespiratory arrest syndrome 15 days, chronic kidney disease 2 months.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20276953
• Report Number: 9680794-2024-00964
• Device Sequence Number: 18116986
• Product Code: DQY
• UDI-Device Identifier: 00801902026408
• UDI-Public: (01)00801902026408(11)210531(17)260430(10)14F21E0250(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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 Expiration Date: 04/30/2026
• Device Catalogue Number: CV-15703-M
• Device Lot Number: 14F21E0250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2021
• 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.
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG