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

Catalog Number CDC-41541-MPKB

Device Problem Material Deformation (2976)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the sheath introducer crumbled back on itself during insertion.No patient harm was reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one dilator/sheath assembly for evaluation.Signs of use in the form of biological material were present on the dilator body.Visual examination of the sheath assembly revealed the sheath tip was slightly crushed and folded over.This appearance is consistent with undue force being applied to the sheath tip.No damaged was observed to the dilator.The total length of the sheath body measured to be 2.75" which is within specifications of 2.625-2.875" per product drawing.The outer diameter of the sheath body measured to be 0.08075" which is within specifications of 0.078 -0.084" per product drawing.The inner diameter of the sheath tip measured to be 0.0065" which is within specifications of 0.064-0.065" per product drawing.A lab inventory 4.5 fr catheter was inserted into the sheath per the instructions for use (ifu).The ifu provided with this kit states, "insert catheter through peel-away sheath to final indwelling position." the catheter was able to pass through the sheath with minimal resistance.The returned dilator was able to be inserted and locked with minimal resistance.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." the customer report of a damaged sheath was confirmed by complaint investigation of the returned sample.The sheath tip was slightly crushed and folded over, which is damage consistent with undue force being applied to the tip.The sample passed all relevant dimensional inspection and a device history record review was performed with no relevant findings.Based on the sample received, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported the sheath introducer crumbled back on itself during insertion.No patient harm was reported.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: 16482499
• MDR Text Key: 310706980
• Report Number: 9680794-2023-00116
• Device Sequence Number: 1
• Product Code: PND
• 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: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: CDC-41541-MPKB
• Device Lot Number: 13F22J0673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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.