MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number	AK-11142-D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "iv fluids noted to be leaking out of introducer".The introducer had been inserted on (b)(6) 2023 in the right internal jugular and a pulmonary artery catheter had been inserted through the introducer.No patient harm reported.The introducer was removed.The patient was reported to be discharged from hospital.
Event or Problem Description
It was reported "iv fluids noted to be leaking out of introducer".The introducer had been inserted on (b)(6) 2023 in the right internal jugular and a pulmonary artery catheter had been inserted through the introducer.No patient harm reported.The introducer was removed.The patient was reported to be discharged from hospital.
Additional Manufacturer Narrative
(b)(4).The customer report of sheath leak could not be confirmed through investigation of the returned sample.The customer returned one mac catheter with its obturator for analysis.Signs of use in the form of biomaterial were observed.Visual analysis of the catheter did not reveal any obvious defects or anomalies.The outer diameter (od) of the distal extension line measured 4.744mm via calibrated micrometer which was within the specification limits of 4.70mm-4.80mm per the distal extension line extrusion product drawing.The inner diameter (id) of the distal extension line measured 0.118" via calibrated pin gauge, or 2.9972mm, which was within the specification limits of 2.90mm-3.00mm per the distal extension line extrusion product drawing.The od of the proximal extension line measured 2.933mm via calibrated micrometer, which was within the specification limits of 2.90mm-3.00mm per the proximal extension line extrusion product drawing.The id of the distal extension line measured 0.085" via calibrated pin gauge, or 2.159mm, which was within the specification limits of 2.11mm-2.21mm per the proximal extension line extrusion product drawing.The valve and mac device were leak tested according to three different parameters.Low pressure leak resistance test states, "using a test pressure of 38-42 kpa (5.51-6.09 psi), there shall be no leakage past the hemostasis valve".The mac catheter was attached to the lab leak tester.With the distal end of the sheath occluded, the sheath was pressurized to 42 kpa for 30 seconds.No leaking was observed.For liquid leakage test, hemostasis valve with mac companion was inserted.The parameters from the low-pressure leak resistance test were repeated with a lab inventory mac companion inserted into the sheath.The sheath was pressurized to 42 kpa for 30 seconds.No leaking was observed.High pressure leak resistance test states, "when tested in accordance with iso, using a test pressure of 300-320 kpa (43.5-46.4 psi) there shall be no leakage sufficient to form a falling drop." with both the distal end of the sheath and the hemostasis valve occluded with the returned obturator, the device was pressurized to 300kpa for 30 seconds.No leaks were detected from any portion of the mac, which indicated that the assembly was intact.A manual tug test confirmed that the extension lines were secure within their respective luer hubs.The ifu provided with the kit informs the user, "do not suture directly to the outside diameter of access device to minimize the risk of cutting or damaging device or impeding device flow".The catheter passed all relevant dimensional and functional requirements including leak testing performed per iso.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, no problem was found.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17470636
• Report Number: 9680794-2023-00558
• Device Sequence Number: 14942949
• Product Code: FOZ
• UDI-Device Identifier: 20801902121916
• UDI-Public: 20801902121916
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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 Expiration Date: 06/30/2025
• Device Catalogue Number: AK-11142-D
• Device Lot Number: 33F23B0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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