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

Catalog Number	CDC-41541-MPKC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: dilator/sheath put over the guidewire to introduce into the patient.The sheath buckled.Additional information: the insertion site was the right basilic.Skin was reported as tough.The dilator was removed in its entirety after it buckled.Another sheath was used to finish the procedure successfully.There was no reported patient harm or consequence.The patient was reported as fine post the procedure.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a peel-away sheath body damaged was able to be confirmed by the photo.The image shows a peel-away sheath still advanced over the dilator with a damaged portion of the tip.A complete visual inspection could not be performed as no sample was returned for analysis.The manufacturing facility was contacted regarding this complaint investigation.They indicated that the appearance of the damage based on the provided photo is consistent with undue force being applied to the peel-away sheath during insertion or removal.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns 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 peel-away sheath body was confirmed by visual inspection of the customer supplied photo.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Based on these circumstances, the customer photo, and the comments from manufacturing, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: dilator/sheath put over the guidewire to introduce into the patient.The sheath buckled.Additional information: the insertion site was the right basilic.Skin was reported as tough.The dilator was removed in its entirety after it buckled.Another sheath was used to finish the procedure successfully.There was no reported patient harm or consequence.The patient was reported as fine post the procedure.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: 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: 18037660
• Report Number: 9680794-2023-00817
• Device Sequence Number: 15289965
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: 10801902205435
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F23D0743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2023
• 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