MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM; INTRODUCER, CATHETER

Catalog Number	CDC-44041-VPS2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported while attempting to peel the peel-away sheath, one side of the white sheath tab broke off.The user used the white portion of the sheath that was still intact and pulled the catheter to the opposite side to break the sheath.The sheath was removed.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
It was reported while attempting to peel the peel-away sheath, one side of the white sheath tab broke off.The user used the white portion of the sheath that was still intact and pulled the catheter to the opposite side to break the sheath.The sheath was removed.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for analysis.Signs of use were observed.Visual analysis of the sheath revealed that the sheath tore incorrectly and separated adjacent to the one of the tabs.A portion of the proximal end of the peel-away extrusion was still molded to the separated tab.Microscopic examination confirmed the damage and revealed that the point of separation was stretched and jagged.It was also noted that the peel-away sheath was split completely down one side of the score line.The other score line was intact.The length of the sheath body measured 2 3/4" , which is within the specification limits of 2 5/8"-2 7/8" per the sheath peel-away product drawing.The outer/inner diameter could not be accurately measured as one side of the score line was completely split.Functional inspection could not be performed due to the damage.Manufacturing was contacted as a part of this complaint investigation.They confirmed that this will need to be further investigated by their facility.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 tearing incorrectly was confirmed through complaint investigation.Visual analysis revealed that one side of the peel-away extrusion tore incorrectly adjacent to one of the tabs.Despite the damage, the sheath met all relevant dimensional 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 manufacturing, the root cause cannot be determined until further analysis can be performed by manufacturing.Therefore, a non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM
• Common Device Name: INTRODUCER, 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: 17607301
• Report Number: 9680794-2023-00605
• Device Sequence Number: 6206487
• Product Code: LJS
• UDI-Device Identifier: 50801902120699
• UDI-Public: 50801902120699
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: 07/22/2024
• Device Catalogue Number: CDC-44041-VPS2
• Device Lot Number: 33F23C0391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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 Age: 85 YR
• Patient Sex: Female