MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN921188
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hematoma (1884); Foreign Body In Patient (2687)
Date of Event	12/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "catheter fragments left in patient's body after removal".Additional information reported that a ct check (including inspection of fragments) was performed, and a haematoma was removed.The retrieval of the fragment was unsuccessful.The condition of the patient is reported to be haemodynamically stable.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The photo revealed two images of a separated catheter body.The customer returned one arterial catheter for analysis.The catheter was separated towards the proximal end of the catheter body.Signs of use in the form of biological material was observed inside the catheter body.Visual analysis also revealed a major kink in the proximal catheter body.Microscopic examination confirmed the damage and revealed that the point of separation had smooth, distinct cuts within the center of the catheter body extrusion.The edges in the center of the extrusion were angled and smooth which is consistent with contact with a sharp instrument.However , there were also signs of deformation in the form of stretching as the catheter extrusion appeared compressed at the point of separation.The kink in the catheter body measured at 11mm from the distal hub.The catheter was separated approximately 38mm from the hub to the point of separation.This is not within the catheter length specification of 162mm-166mm per catheter product drawing.This is expected based on the customer report which stated that the separated catheter fragment could not be removed from the patient.The catheter body outer diameter (not near the point of separation) measured 1.26mm mm, which is within the specification limits of 1.24mm-1.30mm per the catheter extrusion product drawing.Although deformed, the catheter body inner diameter was able to be measured at the distal tip and measured 0.033", or approximately 0.86mm, which is still within the specification limits of 0.81mm-0.86mm per the catheter extrusion product drawing.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.The instructions for use (ifu) provided with the kit informs the user , "warning: do not use scissors to remove dressing to reduce the risk of cutting the catheter.Remove catheter securement device or sutures being careful not to cut catheter.Remove catheter slowly.Warning: do not use excessive force in removing catheter.If resistance is met on removal, stop and follow institutional policies and procedures for difficult to remove catheters." the customer report of a separated arterial catheter was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the catheter body was separated towards the proximal end.Microscopic examination confirmed the damage and revealed that the point of separation had smooth , distinct cuts within the center of the catheter body extrusion.The edges in the center of the extrusion were angled and smooth which is consistent with contact with a sharp instrument.However, there were also signs of deformation in the form of stretching as the catheter extrusion appeared compressed at the point of separation.There were no findings that would suggest a manufacturing related defect.A device history record review was performed with no relevant findings.Based on the customer report and the returned sample, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "catheter fragments left in patient's body after removal".Additional information reported that a ct check (including inspection of fragments) was performed, and a haematoma was removed.The retrieval of the fragment was unsuccessful.The condition of the patient is reported to be haemodynamically stable.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 16CM
• 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: 21110676
• Report Number: 3006425876-2025-00052
• Device Sequence Number: 7474121
• Product Code: DQY
• UDI-Device Identifier: 00801902102829
• UDI-Public: (01)00801902102829(11)220106(17)261231(10)71F22A0095(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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 Model Number: IPN921188
• Device Catalogue Number: SAC-01618
• Device Lot Number: 71F22A0095
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown