MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number CDC-41541-MPKC

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the sheath kinked and rolled back at the transition during the procedure and a replacement kit was needed to complete the procedure".No patient harm reported.The sheath was removed in its entirety.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 was 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 0.0815", which is within the specification limits of 0.0780"-0.0840" 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.Light resistance was encountered at the sheath tip due to the damage; however, the dilator was able to fully lock onto the sheath tabs.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 the current assembly process and inspection criteria is reviewed 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 relevant findings were identified.Non-conformances were initiated to address the issue of a sheath not tearing correctly.Given that the damage for this complaint involves a defective tip, it is unknown if these findings are relevant to this failure mode at this time.The ifu provided with the kit cautions the user, "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.The sheath met all relevant dimensional and functional requirements.Based on the customer report, the sample received, and the comments from r & d, this failure will need to be further investigated by manufacturing.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.

Event Description

It was reported "the sheath kinked and rolled back at the transition during the procedure and a replacement kit was needed to complete the procedure".No patient harm reported.The sheath was removed in its entirety.The patient's condition is reported as fine.

• 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 Key: 17843836
• MDR Text Key: 324593170
• Report Number: 9680794-2023-00719
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: 10801902205435
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F23D0743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.