MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM; INTRODUCER, CATHETER

Model Number	IPN037300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the peel-away sheath was broken into 4 pieces down the middle and in half.No pieces were retained in the patient.No medical intervention required.The patient's condition is reported as fine.
Event or Problem Description
It was reported the peel-away sheath was broken into 4 pieces down the middle and in half.No pieces were retained in the patient.No medical intervention required.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied three photos for evaluation.Visual analysis of the photos revealed that the peel-away catheter had separated down the extrusion.A device history record review was performed, and a potentially relevant finding was identified.Corrective action was initiated for the peel-away extrusion batch 34c21c0329 to address the issue of a peel-away sheath tearing incorrectly.Despite this, it cannot be confirmed if this is the same failure mode involved with this complaint as the sample was not returned for analysis.The ifu provided with the kit informs the user, "grasp tabs of peel-away sheath and pull apart, away from catheter, while withdrawing from vessel until sheath splits down its entire length".The report of a damaged peel-away sheath was confirmed through complaint analysis of the customer supplied photos.The images show that the peel away sheath had separated along the extrusion; however , the actual complaint sample was not returned for evaluation.The probable cause of the damaged sheath could not be officially confirmed based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12956131
• Report Number: 9680794-2021-00642
• Device Sequence Number: 14522447
• Product Code: DYB
• UDI-Device Identifier: 30801902120756
• UDI-Public: 30801902120756
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 11/16/2021

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 Expiration Date: 05/31/2023
• Device Model Number: IPN037300
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: 13F21J1108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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
• Patient Sex: Unknown