MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN919527
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "the sheath split inside patient while trying to thread picc into patient." additional information received stated that all pieces of the sheath were retrieved from the patient without medical or surgical intervention.Furthermore, the catheter was able to be placed.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, defective peel-away catheter for analysis.Signs of use in the form of biological material were observed.Visual examination revealed one sheath tab was separated from the sheath body.A portion of the sheath body remained molded to the hub.The separation points appeared stretched and jagged.One score line was separated completely down the extrusion.The other score line was still intact.The total length of the sheath body measured to be 2 13/16" which is within the specifications of 2 5/8"-2 7/8" per product drawing.The sheath inner and outer diameter could not be accurately measured as one of the score lines had already become split.Functional testing was performed by splitting the score line (score line still connected) down the extrusion.The score line appeared to split as intended.Performed per ifu statement, "grasp tabs of peel-away sheath and pull away from the catheter, while withdrawing from vessel until sheath splits down its entire length".A manual tug test confirmed the remaining tab was fully secured to the sheath body.A device history record review was performed, and no relevant findings were identified.The ifu provided with the 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 venospasm, vessel perforation, bleeding, or component damage".The report of a peel-away sheath tearing incorrectly was confirmed through complaint investigation.Visual examination revealed one sheath tab was separated from the sheath extrusion.The sheath met all relevant dimensional requirements.The appearance of the defect is consistent with damage due to a manufacturing process.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the sheath split inside patient while trying to thread picc into patient." additional information received stated that all pieces of the sheath were retrieved from the patient without medical or surgical intervention.Furthermore, the catheter was able to be placed.Patient condition reported as "fine".

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 16700405
• Report Number: 9680794-2023-00238
• Device Sequence Number: 5617155
• Product Code: LJS
• UDI-Device Identifier: 10801902188219
• UDI-Public: 10801902188219
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• 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): 03/13/2023

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
• Device Expiration Date: 10/31/2023
• Device Model Number: IPN919527
• Device Catalogue Number: CDC-44052-VPS2
• Device Lot Number: 13F22H0789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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