MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-21242-MMC1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported issue with introducer having fluid coming back up into the distal side port, air bubbles coming up the proximal line, and fluid leaking from the juncture hub at the skin.It was reported the catheters work great in the or and then 1-9 days later experience the issue.The introducer was removed and a different catheter was placed.No patient injury reported.
Additional Manufacturer Narrative
(b)(4).As per the medwatch report received on (b)(6) 2023, rij pa 9 french double lumen introducer us guided placed and removed next day.Swan cath was not working properly.Air was being drawn back and needed to be removed from the patient.This was not great as we needed to measure cardiac outputs via the swan as patient was on epinephrine.Line was not saved.The customer report of a catheter leak could not be confirmed through investigation of the returned sample.The customer provided seven photos for analysis; however, no obvious damage or anomalies were observed.The customer returned one mac for analysis.Definite signs of use in the form of biomaterial were observed on the catheter.Visual analysis of the catheter did not reveal any obvious defects or anomalies.The outer diameter (od) of the distal extension line measured 4.795mm 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 0.116" via calibrated pin gauge, or 2.9464mm, 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 2.913mm 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 proximal 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.As per low pressure leak resistance test: "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 or lumen crossover was observed.As per liquid leakage - hemostasis valve with mac companion inserted.The parameters from the low-pressure leak resistance test were repeated with a lab inventory 7fr mac companion inserted into the sheath.The sheath was pressurized to 42 kpa for 30 seconds and no leaks were observed from the hemostasis valve.As per high pressure leak resistance test: "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.The extension lines were connected individually to the leak tester, and when pressurized, no catheter backflow or 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 lidstock product drawing was reviewed as part of this complaint investigation.It was confirmed that the lab inventory 7fr mac catheter is compatible with 7-7.5 fr catheters.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".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.
Event or Problem Description
Customer reported issue with introducer having fluid coming back up into the distal side port, air bubbles coming up the proximal line, and fluid leaking from the juncture hub at the skin.It was reported the catheters work great in the or and then 1-9 days later experience the issue.The introducer was removed and a different catheter was placed.No patient injury reported.

• Brand Name: ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 17729068
• Report Number: 9680794-2023-00660
• Device Sequence Number: 12231171
• Product Code: FOZ
• UDI-Device Identifier: 10801902112054
• UDI-Public: 10801902112054
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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 Catalogue Number: ASK-21242-MMC1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown