MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH KIT: 20GA X 5"; CATHETER, PERCUTANEOUS

Model Number	IPN920537
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and 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
Customer reported patient lost consciousness due to "a clot in the catheter or air".Unknown if the issue was with the catheter or edwards tubing.No further information was available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The customer returned one, arterial catheter for analysis.Signs of use in the form of biological material was observed.Visual analysis revealed slight bending across the catheter body; however, no distinct kinks were observed.No other defects or anomalies were observed.The catheter body total length (per measurement a in the catheter product drawing) measured 6", which is within the specification limits of 5 7/8"-6 1/8".The catheter body outer diameter measured 0.0450", which is within the specification limits of 0.0440"-0.0460" per the catheter extrusion product drawing.The catheter body inner diameter at the proximal end measured 0.027", which is within the specification limits of 0.027"-0.029" per the catheter extrusion product drawing.A lab inventory guide wire with a diameter of.025" was inserted through the catheter body.Resistance was encountered; however, the guide wire was able to pass completely through the catheter.While passing, large quantities of congealed biological material was observed exiting the catheter body.Once cleared, the guide wire was inserted a second time and passed with little to no difficulty.Performed per ifu statement, "thread tip of catheter over guidewire".The ifu provided with the kit informs the user, "maintain catheter patency according to institutional policies, procedures and practice guidelines".The ifu also states, "do not apply tape, staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow, or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations".The report of a blocked catheter was confirmed through complaint investigation.Visual analysis revealed slight bending on the catheter body.Further analysis revealed a build-up of congealed biological material inside the catheter body.Once cleared, the catheter operated as intended.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.1.-brand name corrected to arrow arterial cath kit: 20ga x 5" section d.4.-catalog# corrected to cc-04100-s.Section d.4.-udi corrected to (b)(4).
Event or Problem Description
Customer reported patient lost consciousness due to "a clot in the catheter or air".Unknown if the issue was with the catheter or edwards tubing.No further information was available at the time of this report.

• Brand Name: ARROW ARTERIAL CATH KIT: 20GA X 5"
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16382103
• Report Number: 9680794-2023-00101
• Device Sequence Number: 6201370
• Product Code: DQY
• UDI-Device Identifier: 00801902067050
• UDI-Public: 00801902067050
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN920537
• Device Catalogue Number: CC-04100-S
• Device Lot Number: UNKNOWN
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: TUBING (EDWARDS MANUFACTURER); TUBING (EDWARDS MANUFACTURER)
• Patient Sex: Unknown