MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3L 7 FR X 30 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the doctor found the swg kinked during used on the patient." a new swg was used.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for evaluation.The photo show a guide wire that contains a kink towards the distal end.Therefore, the customer report is confirmed.The customer also returned one opened cvc set containing one guide wire for analysis.The guide wire was returned within its advancer tubing and was kinked.Visual inspection of the returned guide wire revealed one kink in its body.Microscopic examination confirmed the damage.The distal j-bend was misshapen.Both welds were observed to be present and appeared to be full and spherical.The kink in the guide wire measured 28mm from the distal end.The total length of the guide wire measured 685mm, which is within the specifications of 679-687mm per product drawing.The guide wire outer diameter measured 0.80mm, which is within the specifications of 0.788-0.826mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the undamaged portions of the guide wire threaded through a lab inventory ars and 18 ga introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds are intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with the 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 customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed a kink in the guide wire body.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "the doctor found the swg kinked during used on the patient." a new swg was used.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3L 7 FR X 30 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: 19077376
• Report Number: 3006425876-2024-00356
• Device Sequence Number: 6424521
• Product Code: DQY
• UDI-Device Identifier: 00801902104809
• UDI-Public: 00801902104809
• 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): 03/20/2024

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
• Device Catalogue Number: CS-14703-E
• Device Lot Number: 71F22J2693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown