MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 3-L 6 FR X 50 CM W/VPS; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45063-VPS2
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " distal tip of peel away sheath began to buckle and fray while inserting into patient.No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine.".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one peel-away sheath with dilator and a sticker label for analysis.Signs of use in the form of biological material were observed on the peel-away catheter over dilator subassembly.Visual analysis revealed that the sheath tip was crimped.Microscopic examination confirmed the damage.The sheath length measured 2 3/4" , which is within the specification limits of 2 5/8"-2 7/8" per the sheath product drawing.The sheath outer diameter measured 0.116", which is within the specification limits of 0.114"-0.120" per the sheath extrusion product drawing.The sheath inner diameter at the proximal end measured 0.090" , which is within the specification limits of 0.084"-0.094 per the sheath extrusion product drawing.The dilator was removed from the sheath body with little to no resistance.Likewise, the dilator was able to be reinserted and locked 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 and manufacturing were consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the sheath tip, including the sheath tip manufacturing process and/or undue force applied unintentionally by the user.Due to the possibility that manufacturing contributed to this damage, they will additionally investigate this issue.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 sheath body was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath tip was crimped.Despite the damage, the sheath met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from r & d/manufacturing , the root cause cannot be determined at this time.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 " distal tip of peel away sheath began to buckle and fray while inserting into patient.No medical intervention required.No patient harm or injury.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI AGBA PICC KIT: 3-L 6 FR X 50 CM W/VPS
• 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: 18949099
• Report Number: 9680794-2024-00283
• Device Sequence Number: 8052296
• Product Code: LJS
• UDI-Device Identifier: 50801902120774
• UDI-Public: 50801902120774
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/27/2024

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: 01/31/2025
• Device Catalogue Number: CDC-45063-VPS2
• Device Lot Number: 33F23K0410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown