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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER
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ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER Back to Search Results
Catalog Number CDC-41541-MPKC
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2023
Event Type  malfunction  
Event Description
It was reported the sheath kinked during the procedure and a replacement kit was needed to complete the procedure.The insertion site was the left brachial vein.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported the sheath kinked during the procedure and a replacement kit was needed to complete the procedure.The insertion site was the left brachial vein.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The customer provided two images showing a peel-away sheath for analysis.Damage to the sheath tip was observed.It was also noted that the dilator was inserted through the sheath, which is the intended assembly.The customer also returned one peel-away sheath with dilator assembly for analysis.Signs of use in the form of biological material were observed on the sheath body.Visual analysis revealed that the sheath tip was crimped/folded.White stress marks were also observed.No other defects were observed on the sheath nor the dilator.The sheath length measured 2 3/4", which is within the specification limits of 2 5/8"-2 7/8" per the sheath with dilator product drawing.The sheath outer diameter measured 0.081", which is within the specification limits of 0.078"-0.084" per the sheath extrusion product drawing.The sheath inner diameter at the proximal end measured 0.066", which is within the specification limits of 0.061"-0.071" per the sheath extrusion product drawing.The returned dilator was able to be removed and re-inserted through the sheath with little to no issue.Performed per ifu statement, "check peel-away sheath placement by holding sheath in place, twisting dilator hub counterclockwise to release dilator hub from sheath hub, withdraw guidewire and dilator sufficiently to allow blood flow".R & d was contacted as part of this complaint investigation.They concluded that we review the current assembly process and inspection criteria to ensure that a damaged sheath is not potentially assembled over the dilator and that the drop test is properly documented and being performed correctly.Any gap between the sheath and dilator would result in difficulty in insertion and the need to apply extra force.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "grasping near skin, advance peel-away sheath/dilator assembly over guidewire with slight twisting motion to a depth sufficient to enter vessel".The ifu also states, "do not withdraw dilator until sheath is well within vessel to reduce risk of damage to sheath tip".The report of a damaged peel-away body was confirmed through complaint investigation.Visual analysis revealed that the sheath tip was crimped/folded.Despite the damage, the sheath met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from r & d, this failure will need to be further investigated by the manufacturing facility.Therefore, the root cause cannot be determined at this time until further analyses can be performed by the manufacturing facility.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
Type of Device
MIDLINE 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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17817764
MDR Text Key324260557
Report Number9680794-2023-00696
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberCDC-41541-MPKC
Device Lot Number33F23D0743
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received10/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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